AccessGUDID - DEVICE: Conexa Reconstructive Tissue Matrix (M32805050030)

GUDID

Device Identifier (DI) Information

Brand Name: Conexa Reconstructive Tissue Matrix
Version or Model: 0505003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0505003
Company Name: LIFECELL CORPORATION

Primary DI Number: M32805050030
Issuing Agency: HIBCC
Commercial Distribution End Date: July 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 157224205 *Terms of Use

Device Description: Conexa 5cm x 5cm Thick Pliable Product, Rotator Cuff

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?
60907	Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial	A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FTL	Mesh, Surgical, Polymeric

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
Storage Environment Temperature: between -8 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 5 Centimeter
Width: 5 Centimeter

Device Record Status

Public Device Record Key: 50d37396-338a-4336-97b1-468b56e33bd2
Public Version Date: October 04, 2023
Public Version Number: 5
DI Record Publish Date: September 17, 2015