FDA.report

BR Surgical, LLC

Primary DI
00840183504229
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR900-7515
Catalog number
BR900-7515
Device description
Complete suction tube set, for ENT Treatment Cabinet (BR900-7510)
Published
2024-07-23
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
ETFUnit, Examining/Treatment, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
ETFUnit, Examining/Treatment, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183504229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183504229008401835042298401835042290840183504229

GMDN Terms

TermDefinition
ENT cabinetA stand-alone, furniture-like device designed to store, display, and provide readily accessible for the operator the instruments, devices, and materials, including the local anaesthetics used in ear/nose/throat (ENT) treatments/procedures. This device is used in hospitals and physician's offices and will typically have a worktop intended to facilitate the intervention. The device may include features, e.g., suction and pressure pumps, fibreoptic-light source, built-in electrical outlets. It will have wheels for easy movement.

Sterilization Methods

Method

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
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
false

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