FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183511623
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR44-41300
Catalog number
BR44-41300
Device description
ROSEN-FISCH Suction Control Adapter, for use with Rosen suction tube
Published
2024-02-21
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
JZFTube, Ear Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183511623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183511623008401835116238401835116230840183511623

GMDN Terms#

Term, Definition table
TermDefinition
Ear canal suction handleA noninvasive, non-powered, hand-held device intended to be connected to, and facilitate manipulation of, an appropriate cannula (not included) for suction/removal (aspiration) of debris from the ear canal during an ear/nose/throat (ENT) procedure; it is not intended for irrigation. It is in the form of a cylinder with an inner lumen which may incorporate a side-hole for low-level suction control (e.g., using the thumb); it does not incorporate a switch(es), valve(s) or button(s). It may include connection tubing. This is a single-use device.

Sterilization Methods#

Method table
Method
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770428588Bausch + LombBausch & Lomb IncorporatedJZF2026-02-11
00757770676491Bausch + LombBausch & Lomb IncorporatedJZF2026-02-11
00757770425044Bausch + LombBausch & Lomb IncorporatedJZF2026-02-04
00757770446629Bausch + LombBausch & Lomb IncorporatedJZF2025-12-12
09348811000743INKAThe Trustee for KAISER FAMILY TRUSTJZF2025-12-02
00757770701230Bausch + LombBausch & Lomb IncorporatedJZF2025-11-16
00757770436842Bausch + LombBausch & Lomb IncorporatedJZF2025-11-14
04250676745668Suction tube with windowSpiggle & Theis Medizintechnik GmbHJZF2025-09-19
00757770452682Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
00757770680498Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
04250676740533Saxby-IrrigatorSpiggle & Theis Medizintechnik GmbHJZF2025-09-11
04250676722539Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722546Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722553Panetti sinus tympani suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722560Panetti sinus tympani suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722577Panetti atticus suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722584Panetti atticus suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722591Panetti suction separatorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722607Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722614Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676733153Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733160Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733177Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733184Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733191Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733207Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733214Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676738547Suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676738554Suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676742865Preyer dissector, sinus tympaniSpiggle & Theis Medizintechnik GmbHJZF2025-09-03