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
00840183530679BR Surgical, LLCBR900-5050-ACSBR900-5050-ACS2025-09-05
00840183529000BR Surgical, LLCBR900-5050-OLYSTZBR900-5050-OLYSTZ2024-11-07
00840183526986BR Surgical, LLCBR900-7110BR900-71102024-07-23
00840183500238BR Surgical, LLCBR900-5050BR900-50502024-07-22
00840183501464BR Surgical, LLCBR900-5050-OLYBR900-5050-OLY2024-07-22
00840183501822BR Surgical, LLCBR900-3105BR900-31052024-07-22
00840183502072BR Surgical, LLCBR900-5050-ACMIBR900-5050-ACMI2024-07-22
00840183510244BR Surgical, LLCBR900-5050-ASBR900-5050-AS2024-07-22
00840183512149BR Surgical, LLCBR900-5050-ACOBR900-5050-ACO2024-07-22
00840183514891BR Surgical, LLCBR900-5050-WOLFBR900-5050-WOLF2024-07-22
00840183517861BR Surgical, LLCBR900-3103BR900-31032024-07-22
00840183522131BR Surgical, LLCBR900-5050-10BR900-5050-102024-07-22
00840183522957BR Surgical, LLCBR900-5050-OLY-6BR900-5050-OLY-62024-07-22
00840183523244BR Surgical, LLCBR900-5050-OLACBR900-5050-OLAC2024-07-22
00840183523312BR Surgical, LLCBR900-5050-PTXBR900-5050-PTX2024-07-22
00840183525491BR Surgical, LLCBR900-5050-7BR900-5050-72024-07-22
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

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