FDA.report

Mucotome

Primary DI
ENOU1970NOU0
Brand
Mucotome
Company
Nouvag AG
Model
1970nou
Device description
Mucotome
Published
2018-08-21
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
ENOU1970NOU0PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+41718466600info@nouvag.com

Regulatory Flags

DUNS number
480610476
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
ENOU4161US0Dispenser DP 30 LipoPlus4161US2017-01-13
ENOU4163US0Dispenser DP 30 LipoPlus4163US2017-01-13
ENOU4180US0Dispenser DP 304180US2017-01-13
ENOU4181US0Dispenser DP 30 LipoPlus4181US2017-01-13
ENOU4186US0Dispenser DP 304186US2018-08-21
ENOU4187US0Dispenser DP 304187US2017-01-13
ENOU4052USA9Suction jar 2L4052usa2021-12-14
ENOU4245USA9Suction jar 4L4245usa2021-12-14
ENOU1043NOU0Surgical handpiece 4:11043nou2021-06-11
ENOU1706A0Tubing set1706a2021-04-19
ENOU1706B0Tubing set1706b2021-04-19
H7871140900111000Dispenser DP 304187-115ang2017-01-13
H7871140900123000Dispenser DP 304187-230ang2017-01-13
ENOU4180230ANG0Dispenser DP 304180-230ang2021-01-12
ENOU33620LipoSurg33622018-08-21
ENOU33920LipoSurg33922018-08-21
ENOU41139Sterilisation container for Mesher41132018-08-21
ENOU41269Silicone mat for sterilisation container for Mesher41262018-08-21
ENOU41279Filter pack for sterilisation container for Mesher41272018-08-21
ENOU1737NOU9Support sleeve with distal protector1737NOU2019-08-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
06975808863086MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863093MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
06975808863109MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-11-28
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
00860013994006TissueMillTISSUEMILL TECHNOLOGIES LLCGFD2025-05-29
06975808860412MTJIANGSU MJD MEDICAL TECHNOLOGY CO.,LTD.GFD2025-05-24
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