FDA.report

Titanium Sternum Triple-clip L

Primary DI
04260029583151
Brand
Titanium Sternum Triple-clip L
Company
MedXpert GmbH
Model
015-01330
Catalog number
015-01330
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
true

Related Records

Contact Domains

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260029583151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04260029583151042600295831514260029583151

GMDN Terms

TermDefinition
Sternal fixation deviceA collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+4976345085360ask-the-xpert@medXpert.de

Regulatory Flags

DUNS number
331019344
Device count
1
DM exempt
false
Premarket exempt
false
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

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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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