FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183524548
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR70-52333
Catalog number
BR70-52333
Device description
EASTMAN Vaginal Retractor, large, size 3, 4" x 1 1/2"
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDLRetractor, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183524548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183524548008401835245488401835245480840183524548

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089039ELMED INCORPORATEDELMED INCORPORATEDHDL2026-03-03
00198506089046ELMED INCORPORATEDELMED INCORPORATEDHDL2026-03-03
00198506088797ELMED INCORPORATEDELMED INCORPORATEDHDL2026-02-25
00198506088827ELMED INCORPORATEDELMED INCORPORATEDHDL2026-02-25
00198506087240ELMED INCORPORATEDELMED INCORPORATEDHDL2025-12-18
00190776409364MillenniumAvalign Technologies, Inc.HDL2025-08-28
00190776414535MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414542MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414566MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414580MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414597MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414603MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414627MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414634MillenniumAvalign Technologies, Inc.HDL2025-08-15
00190776414641MillenniumAvalign Technologies, Inc.HDL2025-08-15
00194613033224MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-08-01
00194613065737MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-08-01
00194613117894MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-08-01
00194613124205MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-08-01
00190776406677MillenniumAvalign Technologies, Inc.HDL2025-07-23
00190776394622MillenniumAvalign Technologies, Inc.HDL2025-05-07
00190776394639MillenniumAvalign Technologies, Inc.HDL2025-05-07
00190776392680MillenniumAvalign Technologies, Inc.HDL2025-05-02
00194613065355MSI Precision Specialty InstrumentsMed Saver, Inc.HDL2025-03-21
00198506081163ELMED INCORPORATEDELMED INCORPORATEDHDL2025-03-12
00198506081170ELMED INCORPORATEDELMED INCORPORATEDHDL2025-03-12
00198506075360ELMED INCORPORATEDELMED INCORPORATEDHDL2025-02-18
00850071684254Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDL2025-01-21
00198506074462ELMED INCORPORATEDELMED INCORPORATEDHDL2025-01-20
00198506074479ELMED INCORPORTEDELMED INCORPORATEDHDL2025-01-20