FDA.reportPublic FDA data

Pectus Bar, Universal 356 mm

Primary DI
04260029584219
Brand
Pectus Bar, Universal 356 mm
Company
MedXpert GmbH
Model
025-14356
Published
2017-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260029584219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260029584219042600295842194260029584219

GMDN Terms#

Term, Definition table
TermDefinition
Rib/rib cage internal fixation/bracing system bracing barA non-sterile implantable device intended to be used with rib grip/anchor implants either for internal fixation of a fracture or to bridge a deficit in the rib cage. It is typically a thin bar (approximately 20 cm long), with or without serrations, made of metal [e.g., titanium (Ti)]. It can be surgically removed when required or remain in situ. This device must 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
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260029580044Sterilizing container (Polyphenylsulfone), P.E.S. ,empty020-00005020-000052017-01-09
04260029580600Sterilizing container (polyphenyl sulfone), StraTos, empty010-00005010-000052017-01-05
04260029580617Sterilizing container (polyphenyl sulfone), StraCos, empty010-00006010-000062017-01-05
04260029580624Sterilizing Container (polyphenyl sulfone), half-size, empty 010-00007010-000072017-01-05
04260029584295Sterilizing Container Trauma010-00008010-000082017-01-05
04260029585452Sterilizing Container Trauma001-20001001-200012017-01-05
04260029580174Pectus Bar Flipper020-00030020-000302017-01-09
04260029580181Pectus Im- and Explantation Lever020-00031020-000312017-01-09
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

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