FDA.report

BR Surgical, LLC

Primary DI
00840183501372
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR66-29110
Catalog number
BR66-29110
Device description
WALTHER Female Urethral Dilator, set of 14 (12FR-38FR), 5"
Published
2024-03-12
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
FBXSound, Urethral, Metal Or Plastic

Product Code Classifications

CodeDeviceSpecialtyClass
FBXSound, Urethral, Metal Or PlasticGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183501372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183501372008401835013728401835013720840183501372

GMDN Terms

TermDefinition
Urethral dilator, reusableA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. 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
false
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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