FDA.report

BR Surgical, LLC

Primary DI
00840183523329
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR70-36524
Catalog number
BR70-36524
Device description
KOGAN Endo Speculum, with screw-lock, 5mm, 9 1/2"
Published
2024-01-30
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
HDFSpeculum, Vaginal, Metal

Product Code Classifications

CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183523329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183523329008401835233298401835233290840183523329

GMDN Terms

TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. 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
00190776418274MillenniumAvalign Technologies, Inc.HDF2026-03-23
B356JB543320American MedicalsAmerican MedicalsHDF2026-02-26
00198506088810ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-25
00198506088773ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-23
00198506088780ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-23
00190776416164MillenniumAvalign Technologies, Inc.HDF2026-02-06
00190776416171MillenniumAvalign Technologies, Inc.HDF2026-02-06
B356JB641170American MedicalsAmerican MedicalsHDF2026-02-06
00190776415594MillenniumAvalign Technologies, Inc.HDF2026-01-28
00190776415259MillenniumAvalign Technologies, Inc.HDF2026-01-27
00190776415266MillenniumAvalign Technologies, Inc.HDF2026-01-27
00198506088278ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-27
00198506087752ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-16
00198506087769ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-16
00198506087202ELMED INCORPORATEDELMED INCORPORATEDHDF2025-12-18
00198506087066ELMED INCORPORATEDELMED INCORPORATEDHDF2025-12-17
00190776415136MillenniumAvalign Technologies, Inc.HDF2025-12-03
00810158218062PRINCETONPrinceton Medical Group, Inc.HDF2025-11-17
M803030915Kogan 2-4mm w/screwMEDGYN PRODUCTS, INC.HDF2025-11-16
00198506067815ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00198506067822ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00198506068324ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00190776410650MillenniumAvalign Technologies, Inc.HDF2025-09-11
00198506085161ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-05
00190776409258MillenniumAvalign Technologies, Inc.HDF2025-08-22
00190776409289MillenniumAvalign Technologies, Inc.HDF2025-08-22
00190776408589MillenniumAvalign Technologies, Inc.HDF2025-08-19
00190776407995MillenniumAvalign Technologies, Inc.HDF2025-08-06
00190776408008MillenniumAvalign Technologies, Inc.HDF2025-08-06
00190776408077MillenniumAvalign Technologies, Inc.HDF2025-08-06