FDA.report

RUSCH

Primary DI
34026704613992
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
IPN048448
Catalog number
5724E
Device description
EQUIP SET: HANDLE + MAC1,2,3,4MIL0,1,2,3
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704612032Direct MarkingGS10
34026704613992PackageGS112In Commercial Distribution
14026704613998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670461203234026704612032
3402670461399234026704613992
1402670461399814026704613998

GMDN Terms

TermDefinition
Rigid laryngopharyngoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device.

Sterilization Methods

Method
High-level Disinfectant

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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