FDA.report

Medicon

Primary DI
04046826148171
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
76.09.07
Catalog number
76.09.07
Device description
Hernandez Ros staple holder 16cm
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
HWRDRIVER, PROSTHESIS

Product Code Classifications

CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826148171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826148171040468261481714046826148171

GMDN Terms

TermDefinition
Surgical staple remover, reusableA surgical instrument made of metal or plastic that is used to remove surgical staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is typically made of high-grade stainless steel with blades at the distal end designed for grasping, opening, and removing surgical staples. 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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