FDA.report

n.a.

Primary DI
04048551161746
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
41304W
Device description
Sinus Burr, sterile, 5x
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
true
Single use
true

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
04048551161746PrimaryGS10
04048551253380Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551161746040485511617464048551161746
04048551253380040485512533804048551253380

GMDN Terms

TermDefinition
Diamond ENT bur, single-useA rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315731430
Device count
5
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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