FDA.report

CARBIDE DRILL BIT- 4MM (STERILE)

Primary DI
B562BITCB30040
Brand
CARBIDE DRILL BIT- 4MM (STERILE)
Company
WISHBONE MEDICAL, INC.
Model
BIT-CB3-004
Published
2019-08-23
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
HTWBit, Drill

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B562BITCB30040PrimaryHIBCC0

GMDN Terms

TermDefinition
Screw-extraction orthopaedic reamer, single-useA surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting edge and a conical thread within the lumen. The device is rotated around the screw shaft to remove a thin layer of bone, either by a surgical power tool or a manual handle, until the internal thread grips the screw for removal. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062355158
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B562PKGS000100Micro Surgery KitPK-GS0001PK-GS00012024-12-30
B562PKGS000200Minor Surgery KitPK-GS0002PK-GS00022024-12-30
B56251300MDG000G10WishBone Plate & Screw System51-300-MDG000G-151-300-MDG000G-12024-01-01
B56211705310200S0Smart Correction11-705-310200S11-705-310200S2023-06-23
B56211705315200S0Smart Correction11-705-315200S11-705-315200S2023-06-23
B56211705320200S0Smart Correction11-705-320200S11-705-320200S2023-06-23
B56211705325200S0Smart Correction11-705-325200S11-705-325200S2023-06-23
B56211705330200S0Smart Correction11-705-330200S11-705-330200S2023-06-23
B56211705335200S0Smart Correction11-705-335200S11-705-335200S2023-06-23
B56211705340200S0Smart Correction11-705-340200S11-705-340200S2023-06-23
B56211705345200S0Smart Correction11-705-345200S11-705-345200S2023-06-23
B56211705350200S0Smart Correction11-705-350200S11-705-350200S2023-06-23
B56211705410200S0Smart Correction11-705-410200S11-705-410200S2023-06-23
B56211705415200S0Smart Correction11-705-415200S11-705-415200S2023-06-23
B56211705420200S0Smart Correction11-705-420200S11-705-420200S2023-06-23
B56211705425200S0Smart Correction11-705-425200S11-705-425200S2023-06-23
B56211705430200S0Smart Correction11-705-430200S11-705-430200S2023-06-23
B56211705435200S0Smart Correction11-705-435200S11-705-435200S2023-06-23
B56211705440200S0Smart Correction11-705-440200S11-705-440200S2023-06-23
B56211705445200S0Smart Correction11-705-445200S11-705-445200S2023-06-23

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