FDA.report

Hahnenkratt

Primary DI
E206H950RX080
Brand
Hahnenkratt
Company
E. Hahnenkratt GmbH
Model
H950RX08
Device description
with thread, Ø 8 mm
Published
2024-09-03
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

Product Codes

CodeName
KAIMirror, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KAIMirror, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E206H950RX080PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
316001098
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
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

Other Devices From This Company

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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
E20642312C31 Hahnenkratt 42312C32024-09-10
E20642312C51Hahnenkratt 42312C52024-09-10
E206423131Hahnenkratt 423132024-09-10
E20642313C31 Hahnenkratt 42313C32024-09-10
E20642313C51Hahnenkratt42313C52024-09-10
E206423141 Hahnenkratt 423142024-09-10

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