FDA.report

Cranial Drill Bit,5 pack

Primary DI
07290109180625
Brand
Cranial Drill Bit,5 pack
Company
MAZOR ROBOTICS LTD
Model
KIT0722-01
Device description
Cranial Drill Bit,5 pack
Published
2017-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290109180625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109180625072901091806257290109180625

GMDN Terms

TermDefinition
Muscle biopsy clampA sterile manual gripping device designed to secure muscle tissue in order to obtain a biopsy sample. It is used to hold a muscle fibre specimen in a longitudinal position to help preserve the original orientation of the fibres, from the sampling stage through analysis of the tissue. It will typically be designed so that, with the in situ sample, it can fit into an automated histological processing/analysing machine. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
532681590
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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