Model: Gel 1 mL Syringe-Demo
DI: 07331689120318
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
46920679-2b26-4aad-9977-b60aae6a2eb3
Distribution Status:
In Commercial Distribution
DUNS Number:
355371873
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07331689120318
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47887
Name: Dermal tissue reconstructive material, microbe-derived, anaesthetic
Definition:
A sterile, bioabsorbable, bacteria-derived substance intended to be injected into the dermis/hypodermis of the skin, lip submucosa, and/or for supraperiosteal administration to add volume by serving as a space-occupying supplement to the intercellular matrix of connective tissue (dermal filler), typically to correct cutaneous contour deformities (e.g., wrinkles, folds, scars) associated with aging, injury, or degenerative lesions; it includes a local anaesthetic agent (e.g., lidocaine). It typically includes bacterial hyaluronic acid (HA) as the principal constituent and is typically preloaded in a disposable syringe; disposable needle(s)/cannula(e) dedicated to injection may be included.
FDA Product Codes
LMH
Implant, Dermal, For Aesthetic Use
Premarket Submissions
Submission Number:
P040024
Supplement Number:
143
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Refrigeration not required
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Do not freeze
Item #3 - Storage Handling Type:
Special Storage Condition, Specify
Item #3 - Storage Handling Special Condition Text:
Do not expose to direct sunlight
Item #4 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #4 - Storage Handling Low - @attributes - Value:
32
Item #4 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #4 - Storage Handling High - @attributes - Value:
77
Item #4 - Storage Handling Type:
Storage Environment Temperature
Item #5 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #5 - Storage Handling Low - @attributes - Value:
0
Item #5 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #5 - Storage Handling High - @attributes - Value:
25
Item #5 - Storage Handling Type:
Storage Environment Temperature