FDA.report

mytaMed

Primary DI
B351732100
Brand
mytaMed
Company
Mytamed, Inc.
Model
7.32.10
Catalog number
7.32.10
Device description
Noyes Nasal Forceps, Serrated
Published
2018-02-16
Public version status
Update
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
KAEForceps, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B351732100PrimaryHIBCC0

GMDN Terms

TermDefinition
Ethmoid punch, reusableA hand-held manual surgical instrument with a cutting/biting action used for the removal of ethmoid bone (bone which separates the cavity of the nose from the membranes of the brain) during a ear/nose/throat (ENT) surgical intervention. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol-grip or ring handles. The working end terminates with sharp, profiled cutting jaws that close over the ethmoid tissue when the handles are squeezed together cutting through it. It is available in various sizes and designs and is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
015903922
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
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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B351B707300BEAR7.07.307.07.302020-05-12
B351B810050BEAR8.10.058.10.052020-05-19
B351B810060BEAR8.10.068.10.062020-05-19
B351B810070BEAR8.10.078.10.072020-05-19

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09008737448912SoftGrip Forceps SR2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
G04362076B0BEARBear-Ent, LLCKAE2026-02-03
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