FDA.report

Medicon

Primary DI
04046826104337
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
62.32.08
Catalog number
62.32.08
Device description
Hartmann Herzfeld ear fcps 8cm str Ø 2.5mm
Published
2020-09-24
Public version status
New
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

Contact Domains

Product Codes

CodeName
KAEFORCEPS, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826104337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826104337040468261043374046826104337

GMDN Terms

TermDefinition
Otologic clampA hand-held manual surgical instrument designed to grasp internal ear structures (e.g., a bone of the ossicles) during an ear/nose/throat (ENT) procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and blade designs that may utilize carbide inserts. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags

DUNS number
315492330
Device count
1
DM exempt
true
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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G04362076B0BEARBear-Ent, LLCKAE2026-02-03
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09348811104199INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
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