FDA.report

Link OptiStems - Instruments

Primary DI
04026575284443
Brand
Link OptiStems - Instruments
Company
WALDEMAR LINK GmbH & Co. KG
Model
17-5270/01
Device description
Radiographic image marker, manual - 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
HTDFORCEPS

Product Code Classifications

CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026575284443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026575284443040265752844434026575284443

GMDN Terms

TermDefinition
Surgical implant handling forcepsA hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. It is made of metal materials and may have one of various designs (e.g., tweezers-, scissors-, alligator-like) whereby the blades are designed to be opened/closed to handle a variety of implantable devices (e.g., orthopaedic joint prosthesis, breast implant, surgical mesh). This is a reusable device intended to be sterilized prior to use.

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

Primary DIBrandModelCatalogPublished
04026575048168General Instrument15-80352026-02-02
04026575080106MP Reconstruction System Instruments134-011/002026-02-02
04026575080175MP Reconstruction System Instruments134-031/002026-02-02
04026575080182General Instrument134-210/002026-02-02
04026575081011MP Reconstruction System - Instruments134-212/002026-02-02
04026575081042MP Reconstruction System Instruments134-041/002026-02-02
04026575081059MP Reconstruction System Instruments134-051/002026-02-02
04026575083183Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-01/012026-02-02
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
04026575090242Endo-Model Knee System - Endo-Model EVO Knee System - LinkOptiStems151-06/062026-02-02
04026575092239General Instrument151-07/072026-02-02
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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00810158219045PRINCETONPrinceton Medical Group, Inc.HTD2026-03-11
00192896122741Micro Alligator ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
00192896122758Brophy Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-03-10
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B382SD9018382010Surgical DirectSurgical Direct, Inc.HTD2026-03-09
B382SD9018382020Surgical DirectSurgical Direct, Inc.HTD2026-03-09
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