FDA.reportPublic FDA data

Modular Retractor System

Primary DI
00810019932502
Brand
Modular Retractor System
Company
Bradshaw Medical, Inc.
Model
MRS-100
Device description
The Intech Modular Retractor System was developed in close cooperation with leading Medical Device companies and surgeons to serve a variety of approaches to the spine. This versatile kit allows for a variety of configurations (1, 2, or 4 blades) to allow the surgeon safe and efficient access to the spine for implant placement. 1 kit with infinite possibilities (i.e.. Midline, pedicle-based and 3 to 4 blades retractor configurations...)
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
00810019932502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019932502008100199325028100199325020810019932502

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument extractorA hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. 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
Kit
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
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00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
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00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17
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