Model: SH3D01BD
Catalog: SH3D01BD
DI: 00801741233494
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
GalaFLEX 3D Scaffold, 5.3 cm x 15.5 cm, Oval
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b93811af-0c60-4342-bd22-df2e8319b391
Distribution Status:
In Commercial Distribution
DUNS Number:
001191048
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
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
Item #1 - Device ID:
00810054980261
Item #1 - Device ID Type:
Previous
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00801741233494
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44688
Name: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Definition:
An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polyglycolide] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.
FDA Product Codes
OOD
surgical film
Device Sizes
Item #1 - Size - @attributes - Unit:
Centimeter
Item #1 - Size - @attributes - Value:
5.3
Item #1 - Size Type:
Width
Item #2 - Size - @attributes - Unit:
Centimeter
Item #2 - Size - @attributes - Value:
15.5
Item #2 - Size Type:
Length
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Do not use if the center of the temperature indicator is black.
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
15
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
25
Item #2 - Storage Handling Type:
Storage Environment Temperature