FDA.reportPublic FDA data

Sternum clip Bar Elongation Pliers

Primary DI
04260029583267
Brand
Sternum clip Bar Elongation Pliers
Company
MedXpert GmbH
Model
010-01530
Catalog number
010-01530
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260029583267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260029583267042600295832674260029583267

GMDN Terms#

Term, Definition table
TermDefinition
Rib/rib cage internal fixation/bracing system bending pliersA hand-held manual surgical instrument designed to be used with a rib/rib cage internal fixation/bracing system for bending the rib grip or bracing bar implants to a specific shape, e.g., to modify the angulation of a rib clip. 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 bend the metal rib grips or bracing bars allowing the surgeon to customize their shape. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
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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