AccessGUDID - DEVICE: ULTRAFIX RC (20845854015978)

GUDID

Device Identifier (DI) Information

Brand Name: ULTRAFIX RC
Version or Model: 10170A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10170A
Company Name: Conmed Corporation

Primary DI Number: 20845854015978
Issuing Agency: GS1
Commercial Distribution End Date: October 03, 2023
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ULTRAFIX RC STITCHPAK, SUTURE ANCHOR WITH ATTACHED #2 (5MM) POLYESTER SUTURE, ROTATOR CUFF, 5 EA

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?
45062	Tendon/ligament bone anchor, non-bioabsorbable	A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MBI	FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960439	000

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
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.9 Millimeter

Device Record Status

Public Device Record Key: a71095e6-1da3-43eb-9b34-872e18cf5967
Public Version Date: October 04, 2023
Public Version Number: 6
DI Record Publish Date: October 24, 2015