FDA.report

n.a.

Primary DI
04048551173435
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
523100
Device description
JOSEPH Nasal Saw, left, 18.5 cm
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
04048551173435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551173435040485511734354048551173435

GMDN Terms

TermDefinition
Manual surgical saw blade, rigidA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a rigid manual hand saw used for cutting bone/tissue when a directional pressure is applied. This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is manually powered in a back and forth motion by the user. This is a reusable device.

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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