FDA.report

BR Surgical, LLC

Primary DI
00840183527730
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR46-90001
Catalog number
BR46-90001
Device description
Myringotomy Mini Set includes, Micro Ear Fcp, Hartmann Ear Specula 2mm-4mm, Buck Ear Curette blunt, Buck Ear Curette sharp, Barbara Needle curved, Day Ear Hook, Farrell Cotton Applicator, Filter, Paper Sterilization Indicators, and Sterilization tray w/mat 12"x5 1/2"x3"
Published
2024-08-09
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
OGSMyringotomy Procedure Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183527730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183527730008401835277308401835277300840183527730

GMDN Terms

TermDefinition
ENT surgical procedure kit, non-medicated, reusableA collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. 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
true
Combination product
false
Lot or batch
false
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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