FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183510701
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR44-17112
Catalog number
BR44-17112
Device description
"GROSS Ear Spoon & Hook, 4 3/4"""
Published
2024-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZESpoon, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZESpoon, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183510701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183510701008401835107018401835107010840183510701

GMDN Terms#

Term, Definition table
TermDefinition
Ear spoonA hand-held manual surgical instrument intended to be used during interventions in the ear to remove or manipulate tissue or anatomical structures. It is usually made of high-grade stainless steel and has a cylindrical handle located centrally from which a shaft protrudes in both directions. These shafts terminate with an operative instrument, one of which is spoon-shaped. The opposite tip may be, e.g., blunt or pointed and possibly at a right angle to the shaft. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840183531430BR Surgical, LLCBR32-47202BR32-472022026-07-22
00840183531980BR Surgical, LLCBR24-67215BR24-672152026-07-22
00840183532017BR Surgical, LLCBR32-47193BR32-471932026-07-22
00840183532024BR Surgical, LLCBR32-47194BR32-471942026-07-22
00840183532031BR Surgical, LLCBR32-47195BR32-471952026-07-22
00840183532093BR Surgical, LLCBR32-38015BR32-380152026-07-22
00840183532154BR Surgical, LLCBR32-24723BR32-247232026-07-22
00840183532161BR Surgical, LLCBR32-23723BR32-237232026-07-22
00840183532178BR Surgical, LLCBR32-23022BR32-230222026-07-22
00840183531232BR Surgical, LLCBR18-21001BR18-210012026-07-21
00840183531720BR Surgical, LLCBR24-25427BR24-254272026-07-21
00840183532185BR Surgical, LLCBR18-68528BR18-685282026-07-21
00840183532192BR Surgical, LLCBR18-68516BR18-685162026-07-21
00840183532222BR Surgical, LLCBR18-27003BR18-270032026-07-21
00840183532239BR Surgical, LLCBR18-27004BR18-270042026-07-21
00840183532383BR Surgical, LLCBR20-10611BR20-106112026-07-21
00840183532475BR Surgical, LLCBR24-19018BR24-190182026-07-21
00840183532499BR Surgical, LLCBR24-32026BR24-320262026-07-21
00840183532628BR Surgical, LLCBR18-30004BR18-300042026-07-21
00840183531423BR Surgical, LLCBR10-18115ABR10-18115A2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250381863497Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863503Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863510Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863527Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863534Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863541Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381863558Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
04250381868713Volkmann sharp spoonSpiggle & Theis Medizintechnik GmbHJZE2025-09-03
00840306823954Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JZE2025-01-17
00311917136295WalgreensWALGREEN CO.JZE2022-02-18
10311917136292WalgreensWALGREEN CO.JZE2022-02-18
00079573109281Ezy DoseAPOTHECARY PRODUCTS, LLCJZE2020-10-16
10079573109288Ezy DoseAPOTHECARY PRODUCTS, LLCJZE2020-10-16
00681131395328EquateWAL-MART STORES, INC.JZE2020-09-21
20681131395322EquateWAL-MART STORES, INC.JZE2020-09-21
00023185002430EZY DOSEAPOTHECARY PRODUCTS, LLCJZE2020-08-24
10023185002437EZY DOSEAPOTHECARY PRODUCTS, LLCJZE2020-08-24