AccessGUDID - DEVICE: OPTIFIX (00801741128950)

GUDID

Device Identifier (DI) Information

Brand Name: OPTIFIX
Version or Model: 0113320
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0113320
Company Name: Davol Inc.

Primary DI Number: 00801741128950
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001191048 *Terms of Use

Device Description: OptiFix Open Absorbable Fixation System, 27 cm length, 5 mm diameter, 20 Fasteners

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45027	Soft-tissue/mesh anchor, bioabsorbable	A bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GDW	STAPLE, IMPLANTABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 27 Centimeter
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: 898b5066-53d3-47bd-8f67-a8d52f6e6fc7
Public Version Date: October 22, 2024
Public Version Number: 5
DI Record Publish Date: January 10, 2018