FDA.report

Tissue Bank Dermatome

Primary DI
00889024376038
Brand
Tissue Bank Dermatome
Company
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Model
00-8831-003-00
Device description
Autoclave Case
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
00889024376038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024376038008890243760388890243760380889024376038

GMDN Terms

TermDefinition
Dermatome handpiece, electrically-poweredAn electrically-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 is a reusable device.

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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00889024647565Stablecut®11-360811-36082023-02-23
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00889024647596Stablecut®5061095061092023-02-23
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00889024647633Stablecut®5061415061412023-02-23
00889024647640Stablecut® Vanguard™32-70036932-7003692023-02-23
00880304537880Stablecut®5061135061132022-10-03
00880304542464Stablecut®5061145061142022-10-03
00889024493254Stablecut®10070100CR110-0701-00C-R12019-02-22

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09348811172082INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
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06975808860184MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
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06975808863031MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
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06975808863055MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863062MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863079MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
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06975808863116MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
08717903490501D100 dermatome setHumeca B.V.GFD2025-08-19
08717903490570Humeca D100 Dermatome bladeHumeca B.V.GFD2025-08-19
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08717903492352Micrograft gauze + cork plate, 1:3, 5-packHumeca B.V.GFD2025-05-20
08717903495421Humeca D42 Dermatome bladeHumeca B.V.GFD2025-05-20
08717903495414Humeca blade for Padgett® model B, C and S dermatomeHumeca B.V.GFD2025-05-20
08717903495407Humeca blade for Aesculap®/Acculan® dermatomeHumeca B.V.GFD2025-05-20
08717903495445Humeca blade for Zimmer® 8801-8821 dermatomeHumeca B.V.GFD2025-05-20
08717903490402D42 dermatome setHumeca B.V.GFD2025-05-20