FDA.reportPublic FDA data

RACK

Primary DI
00810019931451
Brand
RACK
Company
Bradshaw Medical, Inc.
Model
MRS-101
Device description
A surgical instrument rack is a specialized device used in healthcare settings, particularly in sterile processing departments and operating rooms. Its primary function is to hold and organize surgical instruments during cleaning, sterilization, and storage.
Published
2025-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810019931451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019931451008100199314518100199314510810019931451

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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

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