FDA.report

n.a.

Primary DI
04048551188859
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
660074SG
Device description
Diamond Abrador, diameter 3.0 mm
Published
2016-09-23
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

Product Codes

CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Product Code Classifications

CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551188859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551188859040485511888594048551188859

GMDN Terms

TermDefinition
Skin abrasion unitA mains electricity (AC-powered) device used for the removal of the skin surface by abrasion (applied by some kind of rotating abrasive tool, e.g., a wire brush or emery disc). It may be used during plastic surgery and can be used for treatments such as the removal of scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities of the skin. This GMDN code may reflect old technology.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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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