FDA.reportPublic FDA data

Wire cutter

Primary DI
04250337117988
Brand
Wire cutter
Company
Joimax GmbH
Model
JINTWC
Published
2021-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HXZCutter, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337117988PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337117988042503371179884250337117988

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical navigation device tracking systemAn assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments typically with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/localizers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337120759deflectorJSBS311509JSBS3115092025-07-25
04250337120766deflectorJSBS311512JSBS3115122025-07-25
04250337120773deflectorJSBS361509JSBS3615092025-07-25
04250337120780deflectorJSBS361512JSBS3615122025-07-25
04250337120797deflectorJSBSR15009JSBSR150092025-07-25
04250337120803deflectorJSBSR15012JSBSR150122025-07-25
04250337119630Endo-Chisel, with handleTEC2737152025-03-24
04250337110569Semi-Flexible Biopsy Forceps, up-bitingJFBF322541U2025-03-17
04250337114024Wing Handle for ReamerRHD1012362025-03-17
04250337119241Endo-Kerrison-ShaftEKS324015402025-03-13
04250337117971Endo-Kerrison-Shaft EKS32303040CU2025-03-12
04250337118312Vaporace®/Vaporgrip® Kabel, L 3,0 mVBFC80302025-02-14
04250337118619Vaporace® Probe bipolar, Area 270 mm – 3.5 mmJVAPA270352025-02-14
04250337118640Vaporace® Probe bipolar, Area 320 mm – 3.5 mmJVAPA320352025-02-14
04250337118978Vaporace® Hand Piece, bipolarJVAH100102025-02-14
04250337120230Vaporace® Probe bipolar, Area 150 mm – 3.5 mmJVAPA150352025-02-14
04250337101741iLESSYS®TSR25010TSR250102022-12-30
04250337102854AdapterFS-ADAPT1FS-ADAPT12022-12-30
04250337102861AdapterFS-ADAPT2FS-ADAPT22022-12-30
04250337100737FlatscreenJFMS1910JFMS19102022-12-30

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