FDA.report

BR Surgical, LLC

Primary DI
00840183504168
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR44-19002
Catalog number
BR44-19002
Device description
DAY Ear Hook, small, 2.5mm tip, 6 1/4"
Published
2024-06-03
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
JYLHook, Microsurgical Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183504168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183504168008401835041688401835041680840183504168

GMDN Terms

TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. 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
G043615080BEARBear-Ent, LLCJYL2026-01-19
G043615090BEARBear-Ent, LLCJYL2026-01-19
G043615100BEARBear-Ent, LLCJYL2026-01-19
09348811108364INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
09348811149886INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
04250381821503Gillies skin hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676710017HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676711625ForkSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676705259Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676705266Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716071Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716088Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676738394HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676735560Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735577Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735584Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735591Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735607Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739582Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739599Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739605Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739612Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739629Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676745248Universal scissorsSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
00757770406265Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770406371Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770410125Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770412631Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770413836Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770417339Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05