FDA.report

icotec Instrument, Drill Sleeve for Template, SW 4 mm

Primary DI
07640140438801
Brand
icotec Instrument, Drill Sleeve for Template, SW 4 mm
Company
icotec AG
Model
39-20
Device description
icotec Instrument, Drill Sleeve for Template, SW 4 mm
Published
2021-01-07
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640140438801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640140438801076401404388017640140438801

GMDN Terms

TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
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

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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
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07640172552728CMORE® System, Distractor45-36045-3602025-11-24
07640172552759CMORE® System, Solid Tap, Ø 5.0 mm45-15045-1502025-11-24

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