FDA.report

Sternum clip Preforming Pliers

Primary DI
04260029583243
Brand
Sternum clip Preforming Pliers
Company
MedXpert GmbH
Model
010-01510
Catalog number
010-01510
Published
2017-05-11
Public version status
Update
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications

CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260029583243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260029583243042600295832434260029583243

GMDN Terms

TermDefinition
Rib/rib cage internal fixation/bracing system crimping pliersA hand-held manual surgical instrument designed to be used with a rib/rib cage internal fixation/bracing system for crimping (tightening) the grip implants around a rib or the holding arms of a grip to a bracing bar. The instrument is typically made of high-grade steel and consists of two arms that form a handle proximally and extend distally through a pivot to form jaws that crimp the metal implants in place. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+4976345085630ask-the-xpert@medXpert.de

Regulatory Flags

DUNS number
331019344
Device count
1
DM exempt
false
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
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04260029583298Sternum Repositioning Forceps010-01580010-015802017-05-11
04260029584714Pectus screwdriver026-000102017-06-30
04260029586565Pectus Bar Stabilizer, Universal, R, 2 x Ø4x8 mm025-020282018-07-10
04260029586572Pectus Bar Stabilizer, Universal, L, 2 x Ø4x8 mm 025-020292018-07-10
04260029580204Pectus Allergy Test Plate020-00060020-000602017-01-09
04260029580235Pectus Bar Template, 178 mm021-07178021-071782017-01-09
04260029580242Pectus Bar Template, 203 mm021-08203021-082032017-01-09
04260029580259Pectus Bar Template, 229 mm021-09229021-092292017-01-09
04260029580266Pectus Bar Template, 254 mm021-10254021-102542017-01-09
04260029580273Pectus Bar Template, 279 mm021-11279021-112792017-01-09
04260029580280Pectus Bar Template, 305 mm021-12305021-123052017-01-09
04260029580297Pectus Bar Template, 330 mm021-13330021-133302017-01-09
04260029580303Pectus Bar Template, 356 mm021-14356021-143562017-01-09
04260029580310Pectus Bar Template, 381 mm021-15381021-153812017-01-09
04260029580327Pectus Bar Template, 406 mm021-16406021-164062017-01-09
04260029580334Pectus Bar Template, 432 mm021-17432021-174322017-01-09
04260029583366Sternum Implant Sizer010-01560010-015602017-05-11
04260029580044Sterilizing container (Polyphenylsulfone), P.E.S. 020-00005020-000052017-01-09
04260029580600Sterilizing container (polyphenyl sulfone), StraTo010-00005010-000052017-01-05
04260029580617Sterilizing container (polyphenyl sulfone), StraCo010-00006010-000062017-01-05

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