AccessGUDID - DEVICE: CODMAN SOFWIRE (10705034002286)

GUDID

Device Identifier (DI) Information

Brand Name: CODMAN SOFWIRE
Version or Model: 46-4040
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 464040
Company Name: Cerenovus, Inc.

Primary DI Number: 10705034002286
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: CODMAN SOFWIRE SS Ti Single Cable with Leader, 1 Cinch, 1 Tightener

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?
61688	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile	A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JDQ	CERCLAGE, FIXATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923869	000
K926116	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7eb2f13-d989-4cb9-a29c-baac7a33a001
Public Version Date: February 19, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2015