FDA.reportPublic FDA data

n.a.

Primary DI
04048551055625
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13272B
Device description
Bite Block, reusable
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FDSGastroscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551055625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551055625040485510556254048551055625

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551161005n.a.408001102018-09-04
04048551291030NAV1408100202018-08-23
04048551325971n.a.408000212016-09-23
04048551160992n.a.408000902016-09-23
04048551277577n.a.408120202018-08-21
04048551325988n.a.408000512016-09-23
04048551336854NAV1408200202018-08-23
04048551337707n.a.408200862018-08-17
04048551337820NAV1408200302018-08-23
04048551271087n.a.408001202016-09-23
04048551387344n.a.408201232019-02-23
04048551387368n.a.408201502017-03-17
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826920325PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920660PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
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04580826921278PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
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