FDA.report

MICRO-LINE

Primary DI
04038653069347
Brand
MICRO-LINE
Company
Aesculap AG
Model
GB231R
Catalog number
GB231R
Device description
micro-Line Dermatome acc. to Wagner
Published
2017-07-31
Public version status
Update
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
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED
GFDDermatome

Product Code Classifications

CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1
GFDDermatomeGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653069347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653069347040386530693474038653069347

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
+1(888)229-3002setworld_orders@aesculap.com

Regulatory Flags

DUNS number
315018218
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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