FDA.report

CMORE® System, Torque Wrench, AO-Coupling

Primary DI
07640172553824
Brand
CMORE® System, Torque Wrench, AO-Coupling
Company
icotec AG
Model
45-400H
Catalog number
45-400H
Device description
CMORE® System, Torque Wrench, AO-Coupling
Published
2025-11-24
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

Related Records

Contact Domains

Product Codes

CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640172553824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640172553824076401725538247640172553824

GMDN Terms

TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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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
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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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