FDA.reportPublic FDA data

Able Medical Devices

Primary DI
00810071391460
Brand
Able Medical Devices
Company
J.M. Longyear Manufacturing, LLC
Model
01-08-3035
Catalog number
01-08-3035
Device description
Valkyrie Reusable Driver Bit
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00810071391460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071391460008100713914608100713914600810071391460

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081307059
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810071391439Able Medical Devices05-04-252805-04-25282024-12-18
00810071391446Able Medical Devices05-05-252805-05-25282024-12-18
00810071391453Able Medical Devices05-06-252805-06-25282024-12-18
00810071391422Valkyrie Thoracic Fixation System01-07-303501-07-30352024-08-14
00810071390845Valkyrie Rib Thoracic Fixation System05-000-0805-000-082023-12-20
00810071390852Valkyrie Rib Thoracic Fixation System05-500-1205-500-122023-12-20
00810071390869Valkyrie Rib Thoracic Fixation System05-300-1605-300-162023-12-20
00810071390876Valkyrie Rib Thoracic Fixation System05-01-252805-01-25282023-12-20
00810071390883Valkyrie Rib Thoracic Fixation System05-2507-105-2507-12023-12-20
00810071390890Valkyrie Rib Thoracic Fixation System05-2507-305-2507-32023-12-20
00810071390906Valkyrie Rib Thoracic Fixation System05-2507-805-2507-82023-12-20
00810071390944Valkyrie Rib Thoracic Fixation System05-2509-105-2509-12023-12-20
00810071390951Valkyrie Rib Thoracic Fixation System05-2509-305-2509-32023-12-20
00810071390968Valkyrie Rib Thoracic Fixation System05-2509-805-2509-82023-12-20
00810071391002Valkyrie Rib Thoracic Fixation System05-2511-105-2511-12023-12-20
00810071391019Valkyrie Rib Thoracic Fixation System05-2511-305-2511-32023-12-20
00810071391026Valkyrie Rib Thoracic Fixation System05-2511-805-2511-82023-12-20
00810071391064Valkyrie Rib Thoracic Fixation System05-2513-105-2513-12023-12-20
00810071391071Valkyrie Rib Thoracic Fixation System05-2513-305-2513-32023-12-20
00810071391088Valkyrie Rib Thoracic Fixation System05-2513-805-2513-82023-12-20

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Primary DI, Brand, Company table
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00199150067459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-20
B922F004800208ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHXX2026-03-11
G832F00500340ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
G832F00503040ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
00840194498975Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00840194498982Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
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10886982351586NASynthes GmbHHXX2026-02-10
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10885862657060CSBExactech, Inc.HXX2026-01-28
00840194498128Response Spine SystemORTHOPEDIATRICS CORP.HXX2026-01-22
00888118145871LEVEL ONEKLS-Martin L.P.HXX2026-01-19
08800308499696INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HXX2026-01-19
07640332471548PERLA ® TLSpineArt SAHXX2026-01-05
00840180543917General InstrumentsALPHATEC SPINE, INC.HXX2025-12-31
00840194495189Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2025-12-31
00199150060115Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00199150062898Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00888480489849Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
00888480489856Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
00888480489863Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29