FDA.reportPublic FDA data

RTCH T STEALTH 11 MM

Primary DI
00810019932854
Brand
RTCH T STEALTH 11 MM
Company
Bradshaw Medical, Inc.
Model
AR-8964-23
Published
2023-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00810019932854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019932854008100199328548100199328540810019932854

GMDN Terms#

Term, Definition table
TermDefinition
Surgical vice gripA heavy-duty, hand-held, surgical instrument with specially designed sturdy handles and gripping jaws intended to be used to securely grip around or hold an object during a surgical intervention. It is made of high-grade stainless steel and is designed like an adjustable wrench and has handles that are self-locking when squeezed closed. The jaws are strong, typically having a concave grip with heavy serrations, and are pivoted with an adjustable ratio-lever exchange to achieve the optimum gripping aperture and gripping force. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
262-925-1374customerservice.ken@intech-medical.com

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

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10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
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B504OMBMLS900040BrasselerProvisionLXH2026-10-20
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B504OMBR9505023020BrasselerProvisionLXH2026-10-20
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B504OMST60070031000BrasselerProvisionLXH2026-10-20
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08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16