FDA.reportPublic FDA data

Titanium Sternum Double-clip M/L

Primary DI
04260029583113
Brand
Titanium Sternum Double-clip M/L
Company
MedXpert GmbH
Model
015-01220
Catalog number
015-01220
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

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
04260029583113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260029583113042600295831134260029583113

GMDN Terms#

Term, Definition table
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 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
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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118145284PURE PECTUSKLS-Martin L.P.HRS2026-05-25
00888118145291PURE PECTUSKLS-Martin L.P.HRS2026-05-25
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftBonebridge AGHRS2026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightBonebridge AGHRS2026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftBonebridge AGHRS2026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightBonebridge AGHRS2026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftBonebridge AGHRS2026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightBonebridge AGHRS2026-05-22
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
05055662971552Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
05055662971569Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
08809986480521CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-03-04
00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535091Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23