FDA.reportPublic FDA data

Hahnenkratt

Primary DI
E206H750RX300
Brand
Hahnenkratt
Company
E. Hahnenkratt GmbH
Model
H750RX30
Device description
with thread, Ø 30 mm
Published
2024-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KAIMirror, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAIMirror, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E206H750RX300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mirror, reusableA hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316001098
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E206103440Hahnenkratt103442024-12-20
E20640X1501E. Hahnenkratt GmbH40X1502024-12-20
E20640X161E. Hahnenkratt GmbH40x162024-12-20
E20641X1031Hahnenkratt41X1032024-12-20
E206B4420HahnenkrattB4422024-12-20
E206B4430HahnenkrattB4432024-12-20
E20640X151E. Hahnenkratt GmbH40X1502024-09-05
E20641X111Hahnenkratt41X112024-09-10
E20641X131Hahnenkratt41X132024-09-10
E20641X51Hahnenkratt41X52024-09-10
E206420010Hahnenkratt 420012024-09-10
E206420020 Hahnenkratt 420022024-09-10
E206420030Hahnenkratt 420032024-09-10
E206420050 Hahnenkratt420052024-09-10
E206420100Hahnenkratt 420102024-09-10
E206421000 Hahnenkratt 421002024-09-10
E206423111 Hahnenkratt 423112024-09-10
E20642311C31 Hahnenkratt 42311C32024-09-10
E20642311C51 Hahnenkratt42311C52024-09-10
E206423121 Hahnenkratt 423122024-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04054462902965evonosevonos GmbH & Co. KGKAI2026-08-21
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04054462902903evonosevonos GmbH & Co. KGKAI2026-08-18
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04054462903023evonosevonos GmbH & Co. KGKAI2026-08-18