FDA.reportPublic FDA data

CELLUTOME™

Primary DI
00849554002968
Brand
CELLUTOME™
Company
KCI USA, INC.
Model
CT-KIT/US
Device description
Cellutome Epidermal Harvesting System Control Unit and Vacuum Head
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GFDDermatome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFDDermatomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849554003699Direct MarkingGS10
00849554002968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849554003699008495540036998495540036990849554003699
00849554002968008495540029688495540029680849554002968

GMDN Terms#

Term, Definition table
TermDefinition
Dermatome, line-poweredA mains electricity (AC-powered) 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. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
102726734
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849554005532SNAP™ STPAL2016-09-24
00849554005549SNAP™ STPALP2016-09-24
00849554005563SNAP™ STPASP2016-09-24
00849554005570SNAP™ STPAMP2016-09-24
00849554005587SNAP™ STPAS2016-09-24
108495540138623M™ V.A.C.®EZ5SMLV001 / EZ5SMLV002EZ5SML2024-03-05
108495540138793M™ V.A.C.®EZ5MEDV001 / EZ5MEDV002EZ5MED2024-03-05
108495540138863M™ V.A.C.®EZ5LRGV001 / EZ5LRGV002EZ5LRG2024-03-05
008495540080143M™ Prevena Restor™ Adaptiform™PRE6001PRE60012022-08-18
008495540083733M™ Prevena Restor™ Adaptiform™PRE6055PRE60552022-08-18
00197998028922Solventum US LLCABT1055ABT10552025-07-29
00197998028946Solventum US LLCABT1055ABT10552025-07-29
00197998032608Solventum US LLCM8275026/5M8275026/52025-07-29
00197998312267Solventum US LLCM8275026/5M8275026/52025-07-29
00197998028939Solventum US LLCABT1055ABT10552025-07-29
00197998028953Solventum US LLCABT1055ABT10552025-07-29
00197998032615Solventum US LLCM8275026/5M8275026/52025-07-29
00197998312274Solventum US LLCM8275026/5M8275026/52025-07-29
00197998028809Solventum US LLCSTPASSTPAS2025-07-23
00197998028816Solventum US LLCSTPAMPSTPAMP2025-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975808860436MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-21
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16975808860112MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
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16975808860181MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
26975808860119MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
26975808860171MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
26975808860188MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2026-05-13
05055445901165SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901172SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901189SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901196SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901202SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901219SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05055445901226SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
05056111338759SurtexSURTEX INSTRUMENTS LTD.GFD2026-05-12
09348811000262INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811000293INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811000316INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
09348811172082INKAThe Trustee for KAISER FAMILY TRUSTGFD2026-01-30
06975808860160MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808860177MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808860184MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808860191MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863000MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863017MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863024MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863031MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863048MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28