FDA.report

BR Surgical, LLC

Primary DI
00840183523008
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR66-17508
Catalog number
BR66-17508
Device description
STOCKMANN Penile Clamp, 3"
Published
2024-06-10
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
FHAClamp, Penile

Product Code Classifications

CodeDeviceSpecialtyClass
FHAClamp, PenileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183523008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183523008008401835230088401835230080840183523008

GMDN Terms

TermDefinition
Surgical penile clampA manual surgical instrument with two blades that are joined at their midpoint, or made of a single alpha-shaped part, intended to stop blood flow to the penis. This is a single-use 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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