AccessGUDID - DEVICE: CoNextions TR Tendon Repair System-Combo Kit (00861445000303)

GUDID

Device Identifier (DI) Information

Brand Name: CoNextions TR Tendon Repair System-Combo Kit
Version or Model: FA0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FA0001
Company Name: CONEXTIONS MEDICAL INC

Primary DI Number: 00861445000303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063692935 *Terms of Use

Device Description: The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
62523	Tendon coaptation implant deployment tool	A sterile, hand-held, mechanical surgical instrument intended to be used to approximate the ends of a lacerated or ruptured tendon and to subsequently deploy a tendon coaptation implant in order to reattach the tendon ends. It is in the form of a stapler-like deployment gun with a proximal control used to deploy the distally-loaded implant. This is a single-use device.	Active	false
62522	Tendon coaptation implant	A sterile, implantable, non-bioabsorbable device intended to be used to reattach the ends of a lacerated or ruptured tendon in order to repair the tendon and restore its function. It is in the form of small suture-like wires made of metal and synthetic polymer materials, and is permanently implanted into the tendon ends with a dedicated stapler-like tool. Disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203855	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: e8e54a3f-9cdb-4929-b474-b6be61952a6e
Public Version Date: May 06, 2022
Public Version Number: 1
DI Record Publish Date: April 28, 2022