FDA.report

BR Surgical, LLC

Primary DI
00840183511074
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR70-36001
Catalog number
BR70-36001
Device description
Redundant Wall Retractor, with ratchet, large, 22x75mm solid blade, 7/8" x 3"
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

Related Records

Contact Domains

Product Codes

CodeName
HDLRetractor, Vaginal

Product Code Classifications

CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183511074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183511074008401835110748401835110740840183511074

GMDN Terms

TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. 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

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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
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Other Devices Sharing Product Codes

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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