FDA.report

BR Surgical, LLC

Primary DI
00840183504199
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR08-82612
Catalog number
BR08-82612
Device description
WAGNER Gum Scissors, straight, sharp/blunt, 4 3/4''
Published
2023-04-17
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
EGNScissors, Surgical Tissue, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183504199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183504199008401835041998401835041990840183504199

GMDN Terms

TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. 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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00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
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