FDA.report

mahe medical GmbH

Primary DI
04050659338173
Brand
mahe medical GmbH
Company
mahe medical gmbh
Model
150-900-202F-S
Device description
Jet Blade,WL=50mm,W=27mm,T=0.40mm _x000D_Synthes conn.,sterile,5pcs./unit _x000D_
Published
2019-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050659338173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050659338173040506593381734050659338173

GMDN Terms

TermDefinition
Oscillating surgical saw blade, single-useA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90? angle to its shaft. It cuts when it is moved in a rapid oscillating motion. This device enables side-cutting action to be performed within a restricted-access area. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
342243334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04050659161702mahe medical GmbH001-0001-006S2019-11-05
04050659161719mahe medical GmbH001-0001-006ST2019-11-05
04050659161726mahe medical GmbH001-0001-006XS2019-11-05
04050659161740mahe medical GmbH001-0001-007S2019-11-05
04050659161757mahe medical GmbH001-0001-007ST2019-11-05
04050659161764mahe medical GmbH001-0001-007XS2019-11-05
04050659161801mahe medical GmbH001-0001-008XS2019-11-05
04050659161825mahe medical GmbH001-0001-009S2019-11-05
04050659161849mahe medical GmbH001-0001-009XS2019-11-05
04050659161863mahe medical GmbH001-0001-010S2019-11-05
04050659161887mahe medical GmbH001-0001-010XS2019-11-05
04050659161948mahe medical GmbH001-0001-012S2019-11-05
04050659161962mahe medical GmbH001-0001-012XS2019-11-05
04050659162013mahe medical GmbH001-0001-014S2019-11-05
04050659162037mahe medical GmbH001-0001-014XS2019-11-05
04050659162051mahe medical GmbH001-0001-016S2019-11-05
04050659162068mahe medical GmbH001-0001-016ST2019-11-05
04050659162075mahe medical GmbH001-0001-016XS2019-11-05
04050659162112mahe medical GmbH001-0001-018XS2019-11-05
04050659162150mahe medical GmbH001-0001-020XS2019-11-05

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