FDA.report

BR Surgical, LLC

Primary DI
00840183513764
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR54-11114
Catalog number
BR54-11114
Device description
TROUSSEAU Tracheal Dilator, 2 blades, 5 1/2"
Published
2024-06-10
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

Related Records

Contact Domains

Product Codes

CodeName
KCGDilator, Tracheal

Product Code Classifications

CodeDeviceSpecialtyClass
KCGDilator, TrachealEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183513764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183513764008401835137648401835137640840183513764

GMDN Terms

TermDefinition
Tracheal surgery dilator, reusableA hand-held manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs and sizes, e.g., a slender hollow or solid body made of metal, plastic or other suitable material in a cylindrical form, or a scissors-like instrument that when activated by closing the two ringed-handles, two or three blunted curved prongs expand in opposite directions. This is a reusable device.

Sterilization Methods

Method
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts

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

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