FDA.report

BR Surgical, LLC

Primary DI
00840183525828
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR70-58134
Catalog number
BR70-58134
Device description
EMMETT Uterine Probe,11 3/4"
Published
2024-06-04
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
HHMSound, Uterine

Product Code Classifications

CodeDeviceSpecialtyClass
HHMSound, UterineObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183525828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183525828008401835258288401835258280840183525828

GMDN Terms

TermDefinition
Uterine probeA slender, rod-like, hand-held manual surgical instrument intended to be used to explore the uterus during a surgical procedure. It is typically intended to be used as a component of a uterine manipulator and as such may have a suction channel for applying a vacuum to fixate the manipulator assembly to the uterus. It is made of metal with an atraumatic tip; it may include graduated markings. 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
00194613017545MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613085841MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613111083MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00190776405670MillenniumAvalign Technologies, Inc.HHM2025-07-18
00190776405687MillenniumAvalign Technologies, Inc.HHM2025-07-18
05010058179585InstrapacROBINSON HEALTHCARE LIMITEDHHM2025-05-21
04049047064725GimmiGimmi GmbHHHM2025-05-20
04049047064923GimmiGimmi GmbHHHM2025-05-20
04049047045267GimmiGimmi GmbHHHM2025-05-14
04049047045328GimmiGimmi GmbHHHM2025-05-14
00190776394882MillenniumAvalign Technologies, Inc.HHM2025-05-08
00190776393175MillenniumAvalign Technologies, Inc.HHM2025-05-05
00194613033750MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613082673MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613087029MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613099855MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00190776388270MillenniumAvalign Technologies, Inc.HHM2024-11-13
05060212057563Sims Uterine SoundDTR MEDICAL LIMITEDHHM2024-10-14
10841742149124HNM MEDICALHNM STAINLESS, LLC.HHM2024-08-30
00190776384906MillenniumAvalign Technologies, Inc.HHM2024-08-26
00840343722890GEN2SURGIX MEDICAL LLCHHM2024-06-28
00810123207183Adler Instrument CompanyAdler, Inc.HHM2024-05-10
04719894432854Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HHM2024-04-08
00840343721978GEN2SURGIX MEDICAL LLCHHM2024-04-05
00840343721985GEN2SURGIX MEDICAL LLCHHM2024-04-05
00840183507121BR Surgical, LLCBR Surgical, LLCHHM2024-03-15
00840183506322BR Surgical, LLCBR Surgical, LLCHHM2024-03-13
00840183506384BR Surgical, LLCBR Surgical, LLCHHM2024-01-30
GYNX43340GynexGYNEX CORPORATIONHHM2023-12-19
GYNX43360GynexGYNEX CORPORATIONHHM2023-12-19