FDA.report

n.a.

Primary DI
04048551055618
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13272
Device description
Bite protector basic
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FDSGastroscope and accessories, flexible/rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551055618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551055618040485510556184048551055618

GMDN Terms

TermDefinition
Intubation teeth protectorA sterile curved device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures. Such protection can be required when the patient is resisting the intubation by clenching their teeth which can be damaged against the metal or plastic blade of the intubation laryngoscope, and/or if the patient has bad teeth that are liable to inadvertent damage, and/or if this is normal hospital procedure to counter liability claims. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
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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