FDA.report

Medicon

Primary DI
04046826088286
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
57.85.07
Catalog number
57.85.07
Device description
Raney scalp clip fcps 16cm f 57.85.03A
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
GDOApplier, surgical, clip

Product Code Classifications

CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826088286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826088286040468260882864046826088286

GMDN Terms

TermDefinition
Scalp clip applier, reusableA hand-held, manually-operated, surgical instrument used for the application (the attachment) of nonimplantable, single-use scalp clips to the margins of a scalp wound/incision during a surgical intervention on the cranium/scalp. Often referred to as a clip gun, it has a pistol-like design and holds an exchangeable, preloaded cassette of scalp clips that are fired into the scalp tissue, with the pull of a trigger, to approximate the margins of the wound/incision until it heals. 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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