FDA.report

NA

Primary DI
00849771051473
Brand
NA
Company
KEY SURGICAL, INC.
Model
BR31276
Catalog number
BR31276
Device description
Bone Reamer Brush, Nylon bristles, stainless steel handle, .276-inch diam, 31-inch long, 3 per package
Published
2023-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTOREAMER

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849771031635PreviousGS10
10849771051470PrimaryGS10
00849771051473Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771031635008497710316358497710316350849771031635
1084977105147010849771051470
00849771051473008497710514738497710514730849771051473

GMDN Terms

TermDefinition
Surgical instrument/endoscope cleaning utensil, reusableA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags

DUNS number
604056226
Device count
3
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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