FDA.report

BR Surgical, LLC

Primary DI
00840183509293
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR16-22625
Catalog number
BR16-22625
Device description
PELKMANN Dressing Forceps, 10"
Published
2023-05-12
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
00840183509293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183509293008401835092938401835092930840183509293

GMDN Terms

TermDefinition
Open-surgery stone-retrieval forcepsA hand-held manual surgical instrument designed to grasp and/or manipulate a calculus (i.e., a kidney or gallbladder stone) during an open surgical procedure; additional intended uses may include soft-tissue manipulation (e.g., polyp removal). It is typically made of high-grade stainless steel and is of scissors-like design with two handles attached to two long curved blades. The handles may be permanently joined or conjoined, usually by pressure, during use. The distal gripping blades may be designed with serrated and/or ringed or slotted grasping surfaces. 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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