OptiFix Open Absorbable Fixation System 0113320

GUDID 10801741128957

Soft-tissue/mesh anchor, bioabsorbable

Primary Device ID	10801741128957
NIH Device Record Key	898b5066-53d3-47bd-8f67-a8d52f6e6fc7
Commercial Distribution Status	In Commercial Distribution
Brand Name	OptiFix Open Absorbable Fixation System
Version Model Number	0113320
Catalog Number	0113320
Company DUNS	001191048
Company Name	Davol Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00801741128950 [Primary]
GS1	10801741128957 [Package] Contains: 00801741128950 Package: BX [5 Units] In Commercial Distribution

GDW	STAPLE, IMPLANTABLE

Steralize Prior To Use	false
Device Is Sterile	true

00801741233678 - GalaFLEX	2025-10-03 GalaFLEX Scaffold, 2.5 cm x 7.6 cm, Rectangle
00801741233685 - GalaFLEX	2025-10-03 GalaFlex Scaffold, 5.0 cm x 15.0 cm, Rectangle
00801741233692 - GalaFLEX	2025-10-03 GalaFlex Scaffold, 5.0 cm x 20.0 cm, Rectangle
00801741233708 - GalaFLEX	2025-10-03 GalaFlex Scaffold, 10.0 cm x 20.0 cm, Rectangle
00801741233715 - GalaFLEX	2025-10-03 GalaFlex Scaffold, 15.0 cm x 20.0 cm, Rectangle
00801741233722 - GalaFLEX LITE	2025-10-03 GalaFlex LITE Scaffold, 2.5 cm x 7.6 cm, Rectangle
00801741233739 - GalaFLEX LITE	2025-10-03 GalaFlex LITE Scaffold, 5.0 cm x 15.0 cm, Rectangle
00801741233746 - GalaFLEX LITE	2025-10-03 GalaFlex LITE Scaffold, 5.0 cm x 20.0 cm, Rectangle