FDA.report

MeshgraftTM II Tissue Expansion System

Primary DI
00889024378780
Brand
MeshgraftTM II Tissue Expansion System
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
00-2195-013-00
Catalog number
00-2195-013-00
Device description
3 TO 1 DERMACARRIER
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FZWExpander, Surgical, Skin Graft

Product Code Classifications

CodeDeviceSpecialtyClass
FZWExpander, Surgical, Skin GraftGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024378780PackageGS120In Commercial Distribution
00889024372566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024378780008890243787808890243787800889024378780
00889024372566008890243725668890243725660889024372566

GMDN Terms

TermDefinition
Skin graft carrierA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags

DUNS number
137354267
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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