FDA.report

BR Surgical, LLC

Primary DI
00840183501495
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
FG74-004658
Catalog number
FG74-004658
Device description
Nail Splitter English Anvil pattern, double-spring, stainless, 5"
Published
2022-11-23
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
GENForceps, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183501495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183501495008401835014958401835014950840183501495

GMDN Terms

TermDefinition
Nail splitting forceps, reusableA hand-held manual instrument designed to cut and split a fingernail or toenail, typically for removal, during a surgical intervention. It comprises two pivoted blades with curved handles and is operated by forcing the lower blade under the nail to be cut and closing the blades together over the nail in a side-cutting action. The cutting blades are typically short and slender. 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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