FDA.reportPublic FDA data

WRENCH, 5mm HEX

Primary DI
00810019931871
Brand
WRENCH, 5mm HEX
Company
Bradshaw Medical, Inc.
Model
MRS-114
Device description
A wrench, 5mm hex is a non-powered, hand-held surgical instrument used to assemble, adjust, and secure the various components of a modular retractor system
Published
2025-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810019931871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019931871008100199318718100199318710810019931871

GMDN Terms#

Term, Definition table
TermDefinition
Spine boardA flat, stiff device intended to be placed under a patient (the patient is usually strapped to this device) to ensure spinal immobilization when a spinal injury is suspected. This device is often used in combination with a head/neck immobilizing device that is also typically fixed or strapped to it. It is typically used after serious accidents and for transport of the patient on a stretcher. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
621830582
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810019931574Concentrical blade - length 50 mmMRS-108-0502025-08-12
00810019931598Concentrical blade - length 70 mmMRS-108-0702025-08-12
00810019931604Concentrical blade - length 80 mmMRS-108-0802025-08-12
00810019931628Concentrical blade - length 90 mmMRS-108-0902025-08-12
00810019931635Concentrical blade - length 100 mmMRS-108-1002025-08-12
00810019931642Concentrical blade - length 110 mmMRS-108-1102025-08-12
00810019931659Concentrical blade - length 120 mmMRS-108-1202025-08-12
00810019931666Concentrical blade - length 130 mmMRS-108-1302025-08-12
00810019931673Plate blade with teeth - length 50 mmMRS-109-0502025-08-12
00810019931680Plate blade with teeth - length 60 mmMRS-109-0602025-08-12
00810019931697Plate blade with teeth - length 70 mmMRS-109-0702025-08-12
00810019931710Plate blade with teeth - length 90 mmMRS-109-0902025-08-12
00810019931727Plate blade with teeth - length 100 mmMRS-109-1002025-08-12
00810019931734Plate blade with teeth - length 110 mmMRS-109-1102025-08-12
00810019931741Plate blade with teeth - length 120 mmMRS-109-1202025-08-12
00810019931758Plate blade with teeth - length 130 mmMRS-109-1302025-08-12
00810019931765Plate blade without teeth - length 50 mmMRS-110-0502025-08-12
00810019931703Plate blade with teeth - length 80 mmMRS-109-0802025-08-11
00810019931772Plate blade without teeth - length 60 mmMRS-110-0602025-08-11
00810019931789Plate blade without teeth - length 70 mmMRS-110-0702025-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376544519InvictusALPHATEC SPINE, INC.LXH2026-07-30
00193082164828ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167416ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167430ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167447ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167454ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167461ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167478ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167492ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00193082167508ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00199150081905Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-30
00810166521703X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523004X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523011X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00850041805863X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
04251631412526BEE PLIF CageNGMedical GmbHLXH2026-07-30
07899258632346Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258634647Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653242Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653259Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653266Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653280Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653297Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
09421028110853Tensioner, AP SizerENZTEC LIMITEDLXH2026-07-30
09421028110877Tensioner, BalancerENZTEC LIMITEDLXH2026-07-30
09421028110884Tensioner, DistractorENZTEC LIMITEDLXH2026-07-30
00198506093487ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093500ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093524ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093548ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29