FDA.report

BR Surgical, LLC

Primary DI
00840183501945
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR66-28114
Catalog number
BR66-28114
Device description
WALTHER Female Urethral Dilator, Ø 14 FR, 5"
Published
2024-01-31
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
GCCDilator, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
GCCDilator, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183501945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183501945008401835019458401835019450840183501945

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
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840183531065BR Surgical, LLCBR08-36111SCSBR08-36111SCS2025-09-29
00840183531089BR Surgical, LLCBR18-48273BR18-482732025-09-29
00840183531133BR Surgical, LLCBR12-32114BR12-321142025-09-29
00840183531171BR Surgical, LLCBR18-15003BR18-150032025-09-29
00840183531201BR Surgical, LLCBR18-15238BR18-152382025-09-29
00840183529239BR Surgical, LLCBR82-11120BR82-111202025-09-05
00840183530341BR Surgical, LLCBR64-19124BR64-191242025-09-05
00840183530365BR Surgical, LLCBR64-12020BR64-120202025-09-05
00840183530532BR Surgical, LLCBR82-14109BR82-141092025-09-05
00840183530549BR Surgical, LLCBR900-7550BR900-75502025-09-05
00840183530563BR Surgical, LLCBR64-16020BR64-160202025-09-05
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183530983BR Surgical, LLCBR99-29332BR99-293322025-09-05
00840183530990BR Surgical, LLCBR99-29333BR99-293332025-09-05
00840183530822BR Surgical, LLCBR99-29453BR99-294532025-09-03
00840183530839BR Surgical, LLCBR99-29454BR99-294542025-09-03
00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
00840183530853BR Surgical, LLCBR99-29456BR99-294562025-09-03
00840183530860BR Surgical, LLCBR99-29457BR99-294572025-09-03
00840183530877BR Surgical, LLCBR99-29458BR99-294582025-09-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850007350338Salivary Access Dilator SetC2DX, INC.GCC2026-02-10
00194613099848MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2025-08-01
00194613094942MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2024-08-15
G586UR96282190Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282210Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282230Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282250Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282270Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282290Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282310Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
00840343718312GEN2SURGIX MEDICAL LLCGCC2023-09-05
00842331192661Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192678Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192685Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192692Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192708Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00840329829445Black & Black SurgicalBLACK & BLACK SURGICAL, INC.GCC2023-05-10
00842962125571HNM MEDICALHNM STAINLESS, LLC.GCC2023-04-03
00842962125526HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125533HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125540HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125557HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125564HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962124345HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124352HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124369HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124376HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124383HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124390HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124406HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23