FDA.report

Medicon

Primary DI
04046826112295
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
66.38.11
Catalog number
66.38.11
Device description
antrum punch 18cm thrcut bwd 2mm
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
KAYPUNCH, NASAL

Product Code Classifications

CodeDeviceSpecialtyClass
KAYPunch, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826112295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826112295040468261122954046826112295

GMDN Terms

TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. 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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04046826532871Medicon68.83.47A68.83.47A2026-01-19
04046826533427Medicon68.83.44A68.83.44A2026-01-19
04046826055158Medicon Tray49.97.1249.97.122025-12-17
04046826068424Medicon52.70.7152.70.712025-12-17

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00840183530716BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00840183530723BR Surgical, LLCBR Surgical, LLCKAY2025-08-26
00848657077194AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAY2025-08-25
00194613081850MSI Precision Specialty InstrumentsMed Saver, Inc.KAY2025-08-01
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