FDA.report

BR Surgical, LLC

Primary DI
00840183512941
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR980-9105
Catalog number
BR980-9105
Device description
Myringotomy Kit, (5) per box, consisting of Ear Tube (Pope), Ear Tube (T Tube), Myringotomy Blade, Plastic Ear Speculum 4mm and 6mm, Gauze 4x4 12 ply (2), Large Cotton Ball (2), 2-Compartment Tray, CSR 20x20 Wrap, 10x15 Peel Pouch
Published
2024-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OGSMyringotomy Procedure Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183512941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183512941008401835129418401835129410840183512941

GMDN Terms

TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile 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 single-use device.

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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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