FDA.reportPublic FDA data

Implant cutting pliers with exchangeable jaw inserts, narrow, 22 cm

Primary DI
04260029580648
Brand
Implant cutting pliers with exchangeable jaw inserts, narrow, 22 cm
Company
MedXpert GmbH
Model
010-00011
Catalog number
010-00011
Published
2017-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04260029580648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260029580648042600295806484260029580648

GMDN Terms#

Term, Definition table
TermDefinition
Rib/rib cage internal fixation/bracing system cutting pliersA hand-held manual surgical instrument designed to be used with a rib/rib cage internal fixation/bracing system for cutting the rib grip or bracing bar implants to a specific size. The instrument is typically made of high-grade steel and consists of two pivoted or multi-pivoted handles that form a handle proximally and when squeezed together, close the jaws distally to bite (cut) through the metal implants. It typically will have replaceable blades. 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
Premarket exempt
true
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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