FDA.report

RAZEK EQUIPAMENTOS

Primary DI
07908882819372
Brand
RAZEK EQUIPAMENTOS
Company
RAZEK EQUIPAMENTOS LTDA
Model
736630900
Device description
Razek Surgical Burrs - BP150A (1,8)
Published
2024-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908882819372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07908882819372079088828193727908882819372

GMDN Terms

TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
898213154
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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07908832572333RAZEK EQUIPAMENTOS7311000002024-12-05
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07908832572456RAZEK EQUIPAMENTOS7342200002024-12-05
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07908832572470RAZEK EQUIPAMENTOS7311500002024-12-05
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07908832572494RAZEK EQUIPAMENTOS7311600002024-12-05
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07908832572555RAZEK EQUIPAMENTOS7311900002024-12-05
07908832572562RAZEK EQUIPAMENTOS7311900012024-12-05
07908832572579RAZEK EQUIPAMENTOS7342300002024-12-05
07908832572586RAZEK EQUIPAMENTOS7342301002024-12-05
07908832572593RAZEK EQUIPAMENTOS7342400002024-12-05
07908832572609RAZEK EQUIPAMENTOS7342401002024-12-05

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