FDA.reportPublic FDA data

WishBox

Primary DI
B562CDRASS150
Brand
WishBox
Company
Wishbone Medical, Inc.
Model
CDRASS15
Device description
Cannulated T15 Screwdriver
Published
2021-06-30
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

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B562CDRASS150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-useA non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device.

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B56251300MDG000G10WishBone Plate & Screw System51-300-MDG000G-151-300-MDG000G-12024-01-01
B562TCX27008US02.7mm x 8mm Ti Cortical ScrewTCX27008-USTCX270082019-11-25
B562TCX27010US02.7mm x 10mm Ti Cortical ScrewTCX27010-USTCX270102019-11-25
B562TCX27012US02.7mm x 12mm Ti Cortical ScrewTCX27012-USTCX270122019-11-25
B562TCX27014US02.7mm x 14mm Ti Cortical ScrewTCX27014-USTCX270142019-11-25
B562TCX27016US02.7mm x 16mm Ti Cortical ScrewTCX27016-USTCX270162019-11-25
B562TCX27018US02.7mm x 18mm Ti Cortical ScrewTCX27018-USTCX270182019-11-25
B562TCX27020US02.7mm x 20mm Ti Cortical ScrewTCX27020-USTCX270202019-11-25
B562TCX27022US02.7mm x 22mm Ti Cortical ScrewTCX27022-USTCX270222019-11-25
B562TCX27024US02.7mm x 24mm Ti Cortical ScrewTCX27024-USTCX270242019-11-25
B562TCX27026US02.7mm x 26mm Ti Cortical ScrewTCX27026-USTCX270262019-11-25
B562TCX27028US02.7mm x 28mm Ti Cortical ScrewTCX27028-USTCX270282019-11-25
B562TCX27030US02.7mm x 30mm Ti Cortical ScrewTCX27030-USTCX270302019-11-25
B562TCX27032US02.7mm x 32mm Ti Cortical ScrewTCX27032-USTCX270322019-11-25
B562TCX27034US02.7mm x 34mm Ti Cortical ScrewTCX27034-USTCX270342019-11-25
B562TCX27036US02.7mm x 36mm Ti Cortical ScrewTCX27036-USTCX270362019-11-25
B562TCX27038US02.7mm x 38mm Ti Cortical ScrewTCX27038-USTCX270382019-11-25
B562TCX27040US02.7mm x 40mm Ti Cortical ScrewTCX27040-USTCX270402019-11-25
B562TCX27045US02.7mm x 45mm Ti Cortical ScrewTCX27045-USTCX270452019-11-25
B562TCX27050US02.7mm x 50mm Ti Cortical ScrewTCX27050-USTCX270502019-11-25

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Primary DI, Brand, Company table
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00840606191616Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191623Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191746Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
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00840606191784Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
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00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
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00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
00824846003205Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
10887587078557NASynthes GmbHHXX2026-07-24
10887587078564NASynthes GmbHHXX2026-07-24
00888118154644LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154651LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154668LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154675LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154682LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154699LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21
00888118154705LEVEL ONE, STERILEKLS-Martin L.P.HXX2026-07-21