BR Surgical, LLC BR46-34230

GUDID 00840183519285

RITTER-HALLE, Frontal Sinus Dilator/Bougie, Ø3,0mm

BR Surgical, LLC

Oesophageal bougie, reusable
Primary Device ID00840183519285
NIH Device Record Key07e55ce2-3c73-4847-bfc8-5b521719a785
Commercial Distribution StatusIn Commercial Distribution
Brand NameBR Surgical, LLC
Version Model NumberBR46-34230
Catalog NumberBR46-34230
Company DUNS134781207
Company NameBR Surgical, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com
Phone1-904-642-1366
Emailcustomerservice@brsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840183519285 [Primary]

FDA Product Code

KCDBougie, Esophageal, Ent

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00840183519285]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-18
Device Publish Date2024-06-10

On-Brand Devices [BR Surgical, LLC]

00857556008369Hysteroscope, autoclavable, Ø 4mm, 70º, 302mm
00857556008352Hysteroscope, autoclavable, Ø 4mm, 30º, 302mm
00857556008345Hysteroscope, autoclavable, Ø 4mm, 12º, 302mm
00857556008338Hysteroscope, autoclavable, Ø 4mm, 0º, 302mm
00857556008321Hysteroscope, autoclavable, Ø 2.9mm, 30º, 302mm
00857556008314Hysteroscope, autoclavable, Ø 2.9mm, 12º, 302mm
00857556008307Cystoscope, autoclavable, Ø 4mm, 70º, 302mm
00857556008291Cystoscope, autoclavable, Ø 4mm, 30º, 302mm
00857556008284Cystoscope, autoclavable, Ø 4mm, 12º, 302mm
00857556008277Cystoscope, autoclavable, Ø 4mm, 0º, 302mm
00857556008260Laparoscope, 4K, autoclavable, Ø 5.5mm, 0º, 302mm
00857556008253Sinus Scope, autoclavable, Ø 4mm, 70º, 175mm
00857556008246Sinus Scope, autoclavable, Ø 4mm, 45º, 175mm
00857556008239Sinus Scope, autoclavable, Ø 4mm, 30º, 175mm
00857556008222Sinus Scope, autoclavable, Ø 4mm, 0º, 175mm
00857556008215Flexible Rhinolaryngoscope, Ø 3.4mm, 300mm
00857556008208Laryngoscope, rigid, autoclaveable, Ø 10mm, 160mm, 70º
00857556008192Laryngoscope, rigid, autoclaveable, Ø 6mm, 160mm, 70º
00857556008185Sinus Scope, autoclavable, Ø 3mm, 70º, 150mm
00857556008178Sinus Scope, autoclavable, Ø 3mm, 45º, 150mm
00857556008161Sinus Scope, autoclavable, Ø 3mm, 30º, 150mm
00857556008154Sinus Scope, autoclavable, Ø 3mm, 0º, 150mm
00857556008147Sinus Scope, autoclavable, Ø 2.7mm, 70º, 187mm
00857556008130Sinus Scope, autoclavable, Ø 2.7mm, 30º, 187mm
00857556008123Sinus Scope, autoclavable, Ø 2.7mm, 0º, 187mm
00857556008116Otoscope, autoclavable, Ø 1.9mm, 100mm, 0º
00857556008109Arthroscope, autoclavable, Ø 3mm, 70º, 150mm
00857556008093Arthroscope, autoclavable, Ø 3mm, 45º, 150mm
00857556008086Arthroscope, autoclavable, Ø 3mm, 30º, 150mm
00857556008079Arthroscope, autoclavable, Ø 3mm, 0º, 150mm
00857556008062Laparoscope, HD, autoclavable, Ø 5.5mm, 0º, 302mm
00857556008055Laparoscope, HD, autoclavable, Ø 5.5mm, 30º, 302mm
00857556008048Laparoscope, HD, autoclavable, Ø 10mm, 0º, 302mm
00857556008031Laparoscope, HD, autoclavable, Ø 10mm, 30º, 302mm
00857556008024Sinus Scope, autoclavable, Ø 2.7mm, 0º, 140 mm
00857556008017Sinus Scope, autoclavable, Ø 2.7mm, 30º, 140 mm
00857556008000Sinus Scope, autoclavable, Ø 2.7mm, 70º, 140 mm
00840183503697ZIEGLER Head Mirror, 3 1/2" (90mm)
00840183500009IUD Scissors, curved, blunt/blunt, 9"
00840183500030BISHOP-HARMON Iris Forceps, straight, 1x2 teeth, 0.8mm tip, 3.5"
00840183500078MATHIEU Foreign Body/IUD Removal Forceps, 3.5mm x 17mm jaw, serrated, 11
00840183500061HALSTED Mosquito Forceps, curved, 5"
00840183500054BEAVER Blade Handle, 5"
00840183517762US ARMY Retractor, double, pair, 8-1/2"
00840183517700WEIL-BLAKESLEY Nasal Forceps, 3.5mm, straight, shaft length 4-3/4", overall 7-1/2"
00840183517694HARTMAN Nasal Polypus Forceps, 3x8mm, 6"
00840183514884VARADY Phlebectomy Mini Extractor, 170mm
00840183513450JACOBS Vulsellum Forceps, straight, 2x2 teeth, 8"
00840183511302CHEVALIER-JACKSON forceps, upward, round cup, 11-3/4”
00840183509118CHEVALIER-JACKSON Bronchial-Laryngeal Forceps, round cup, 4mm, 11-3/4"

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