Model: FR3D03BD
Catalog: FR3D03BD
DI: 00801741234408
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
GalaFLEX 3DR Scaffold, 6.4 cm x 18.5 cm, Oval
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cce5a948-3b4c-478b-8ae7-f1af95ee6462
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:
00801741234408
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00810054980025
Item #2 - Device ID Type:
Previous
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:
6.4
Item #1 - Size Type:
Width
Item #2 - Size - @attributes - Unit:
Centimeter
Item #2 - Size - @attributes - Value:
18.5
Item #2 - Size Type:
Length
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
15
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
25
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Do not use if the center of the temperature indicator is black.