FDA.reportPublic FDA data

BR Surgical, LLC

Primary DI
00840183513948
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR48-26514
Catalog number
BR48-26514
Device description
"DOYEN-JANSEN (MOLT) Mouth Gag, 5 1/2"""
Published
2024-03-12
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
KBNGag, Mouth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840183513948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183513948008401835139488401835139480840183513948

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, adjustable, reusableA mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. 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

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