FDA.report

Link OptiStems - Instruments

Primary DI
04026575284740
Brand
Link OptiStems - Instruments
Company
WALDEMAR LINK GmbH & Co. KG
Model
17-5100/08
Device description
Bone file/rasp, manual, reusable - Endo Model Knee System
Published
2023-02-28
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

Product Codes

CodeName
HTRRASP

Product Code Classifications

CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026575284740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026575284740040265752847404026575284740

GMDN Terms

TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315675488
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company

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04026575081042MP Reconstruction System Instruments134-041/002026-02-02
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04026575083206Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-05/052026-02-02
04026575083664Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-02/022026-02-02
04026575083718Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-03/032026-02-02
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04026575092291General Instrument151-08/082026-02-02
04026575129904MP Reconstruction System Instruments134-071/002026-02-02
04026575129928MP Reconstruction System Instruments134-081/002026-02-02
04026575131426MP Reconstruction System Instruments134-091/002026-02-02
04026575181926MP Monoblock Hip Stem Instruments136-021/002026-02-02
04026575181988MP Monoblock Hip Stem Instruments136-031/002026-02-02
04026575182022MP Monoblock Hip Stem Instruments136-011/002026-02-02

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