AccessGUDID - DEVICE: MeshgraftTM II Tissue Expansion System (00889024372559)

GUDID

Device Identifier (DI) Information

Brand Name: MeshgraftTM II Tissue Expansion System
Version or Model: 00-2195-012-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-2195-012-00
Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Primary DI Number: 00889024372559
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137354267 *Terms of Use

Device Description: 1.5 TO 1 DERMACARRIER

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":	Yes
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?
47924	Skin graft carrier	A sterile device in the form of a flat, rectangular plate designed to support a skin graft (a section of donor skin from another part of a patient's body) while the graft is being perforated in a skin graft mesher in preparation for grafting to the treatment site. It is typically made of disposable plastic material. The carrier is also used to transfer the perforated graft from the mesher to the grafting site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZW	Expander, Surgical, Skin Graft

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Device Size Text, specify: '1.5 in to 1 in Expansion Ratio

Device Record Status

Public Device Record Key: 591ce981-e4c2-43bb-89d1-9f129c8df98a
Public Version Date: October 01, 2020
Public Version Number: 1
DI Record Publish Date: September 23, 2020