FDA.reportPublic FDA data

VADER Pedicle System, Rod Length Forceps

Primary DI
07640164846422
Brand
VADER Pedicle System, Rod Length Forceps
Company
icotec AG
Model
42-716
Catalog number
42-716
Device description
VADER Pedicle System, Rod Length Forceps
Published
2019-08-15
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640164846422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640164846422076401648464227640164846422

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41717570000info@icotec.ch

Regulatory Flags#

DUNS number
480789465
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
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640172553916KONG-TL VBR System, Guiding Sleeve for locking screwdriver44-05144-0512026-01-29
07640172552544CMORE® System, Awl45-01045-0102025-11-24
07640172552551CMORE® System, Pedicle Probe, Straight45-02045-0202025-11-24
07640172552568CMORE® System, Drill Guide Sleeve45-03045-0302025-11-24
07640172552575CMORE® System, Drill Guide Stop45-030-145-030-12025-11-24
07640172552582CMORE® System, Drill Bit, Ø 2.3 mm45-04045-0402025-11-24
07640172552599CMORE® System, Feeler45-07045-0702025-11-24
07640172552605CMORE® System, In-line Handle, AO Coupling45-10045-1002025-11-24
07640172552612CMORE® System, Palm Handle, AO Coupling45-11045-1102025-11-24
07640172552629CMORE® System, Solid Tap, Ø 4.0 mm 45-14045-1402025-11-24
07640172552636CMORE® System, Solid Tap, Ø 4.5 mm45-14545-1452025-11-24
07640172552643CMORE® System, Screwdriver Shaft, T1545-21045-2102025-11-24
07640172552650CMORE® System, Tulip Aligner 45-22045-2202025-11-24
07640172552674CMORE® System, Template for Rods CT1, CT2, R12045-24045-2402025-11-24
07640172552681CMORE® System, Rod Cutter 45-25045-2502025-11-24
07640172552698CMORE® System, French Rod Bender 45-26045-2602025-11-24
07640172552704CMORE® System, Rod Gripper45-28045-2802025-11-24
07640172552711CMORE® System, Compressor45-34045-3402025-11-24
07640172552728CMORE® System, Distractor45-36045-3602025-11-24
07640172552759CMORE® System, Solid Tap, Ø 5.0 mm45-15045-1502025-11-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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