FDA.report

Dermatome Neutral

Primary DI
00889024487697
Brand
Dermatome Neutral
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
8870N200
Catalog number
8870N200
Device description
Width Plate, Neutral, 2 Inches
Published
2021-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GFDDermatome

Product Code Classifications

CodeDeviceSpecialtyClass
GFDDermatomeGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024487697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024487697008890244876978890244876970889024487697

GMDN Terms

TermDefinition
Dermatome handpiece, pneumaticA pneumatically-powered, hand-held surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade (not included). This instrument will typically be driven by compressed gas [e.g., surgical-grade air, nitrogen (N2)] from a medical gas supply system. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Width2Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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