FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183518905
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR42-10200
Catalog number
BR42-10200
Device description
LIEBERMAN Eye Speculum, solid blades
Published
2023-03-10
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
HNCSpecula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183518905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183518905008401835189058401835189050840183518905

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Ethylene Oxide

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189451681Surgical DesignSurgical Design, Inc.HNC2026-05-23
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00810189451711Surgical DesignSurgical Design, Inc.HNC2026-05-23
00757770683741Bausch + LombBausch & Lomb IncorporatedHNC2026-02-04
05056785302988Kratz Plastic Mechanical SpeculumBLINK MEDICAL LIMITEDHNC2026-02-04
05056785303008Plastic Solid Bladed Mechanical SpeculumBLINK MEDICAL LIMITEDHNC2026-02-04
00840319758533Hayden MedicalHayden Medical, Inc.HNC2025-12-31
00840319758380Hayden MedicalHayden Medical, Inc.HNC2025-12-24
00852194002113HAI SpeculaHightech American Industrial Labs IncHNC2025-12-16
00757770652013Bausch + LombBausch & Lomb IncorporatedHNC2025-11-14
05060480409538Speculum LeibingerBLINK MEDICAL LIMITEDHNC2025-09-18
00190776410742MillenniumAvalign Technologies, Inc.HNC2025-09-12
00190776409456MillenniumAvalign Technologies, Inc.HNC2025-09-02
00190776408411MillenniumAvalign Technologies, Inc.HNC2025-08-08
00757770461974Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770481828Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770502462Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770503292Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770636891Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
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