FDA.report

BR Surgical, LLC

Primary DI
00840183525958
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR46-20165
Catalog number
BR46-20165
Device description
MCGEE Oval Window Rasp, angled 20 degree, Small .016 mm diameter rasp 6 1/2"
Published
2024-06-03
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
JYYRasp, Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYYRasp, EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183525958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183525958008401835259588401835259580840183525958

GMDN Terms

TermDefinition
Middle ear file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape and smooth the bony structures of the middle ear. It is typically used during ear/nose/throat (ENT) or plastic surgery; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags

DUNS number
134781207
Device count
1
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
false
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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