FDA.report

Medicon

Primary DI
04046826129668
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
71.11.92
Catalog number
71.11.92
Device description
adenotome blade fig 2 16mm
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
KBHADENOTOME

Product Code Classifications

CodeDeviceSpecialtyClass
KBHAdenotomeEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826129668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826129668040468261296684046826129668

GMDN Terms

TermDefinition
AdenotomeA hand-held manual surgical instrument designed to excise hypertrophic lymphoid tissue in the nasopharynx (i.e., pharyngeal tonsils or adenoids) during a procedure known as an adenoidectomy. It is typically a long, slender instrument with cutting blades at the working end, and a handle with a mechanism to operate the blades. It is available in various designs and sizes and may be a one-piece instrument or require the insertion of the blades into the handle. 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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