FDA.report

BR Surgical, LLC

Primary DI
00840183526795
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR12-47116
Catalog number
BR12-47116
Device description
MIXTER Hemostatic Forcep, 6 1/4"
Published
2024-05-20
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
HRQHemostat

Product Code Classifications

CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183526795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183526795008401835267958401835267950840183526795

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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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