SAIPH® 293-802

GUDID 05055455519794

Saiph® Trial Bearing Green. Right.10mm. Reusable Class IIa instruments use for SAIPH® Knee System. Surgical instrument used as trials during joint replacement surgery.

MATORTHO LTD

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 05055455519794
• NIH Device Record Key: b57dd706-b3ca-43cb-b72a-935a381cedf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAIPH®
• Version Model Number: 293-802
• Catalog Number: 293-802
• Company DUNS: 216819863
• Company Name: MATORTHO LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055455519794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140222

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

[05055455519794]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-26
• Device Publish Date: 2021-01-18

On-Brand Devices [SAIPH®]

• 05055455518001: Femoral Trial Left, Size 1. Reusable Class IIa instruments use for SAIPH® Knee System. Surgica
• 05055455519503: Saiph® Trial Bearing Red. Left.12mm
• 05055455519497: Saiph® Trial Bearing Red. Left.10mm
• 05055455519435: Saiph® Trial Bearing Yellow. Right.10mm
• 05055455519428: Saiph® Trial Bearing Yellow. Left.20mm
• 05055455519411: Saiph® Trial Bearing Yellow. Left.18mm
• 05055455519404: Saiph® Trial Bearing Yellow. Left.16mm
• 05055455519398: Saiph® Trial Bearing Yellow. Left.14mm
• 05055455519381: Saiph® Trial Bearing Yellow. Left.12mm
• 05055455519374: Saiph® Trial Bearing Yellow. Left.10mm
• 05055455518803: Tibial Webbing Chisel Guide C to F
• 05055455518797: Tibial Webbing Chisel Guide A to B
• 05055455518773: Variable Spacer
• 05055455518759: Tibial Webbing Chisel Size 6
• 05055455518742: Tibial Webbing Chisel Size 5
• 05055455518735: Tibial Webbing Chisel Size 4
• 05055455518728: Tibial Webbing Chisel Size 3
• 05055455518711: Tibial Webbing Chisel Size 2
• 05055455518704: Tibial Webbing Chisel Size 1
• 05055455518698: Saiph® Femoral Impactor
• 05055455518681: Saiph® Femoral Spacer. Green
• 05055455518674: Saiph® Femoral Spacer. Blue
• 05055455518667: Saiph® Femoral Spacer. Red
• 05055455518650: Saiph® Femoral Spacer. Yellow
• 05055455518568: Dual Ended Tibial Spacer. 20 mm
• 05055455518551: Dual Ended Tibial Spacer. 18 mm
• 05055455518544: Dual Ended Tibial Spacer. 16 mm
• 05055455518537: Dual Ended Tibial Spacer. 14 mm
• 05055455518520: Dual Ended Tibial Spacer. 12 mm
• 05055455518513: Dual Ended Tibial Spacer . 10 mm
• 05055455518483: Tibial Drill Guide Size F
• 05055455518476: Tibial Drill Guide Size E
• 05055455518469: Tibial Drill Guide Size D
• 05055455518452: Tibial Drill Guide Size C
• 05055455518445: Tibial Drill Guide Size B
• 05055455518438: Tibial Drill Guide Size A
• 05055455518421: Tibial Template Size F
• 05055455518414: Tibial Template Size E
• 05055455518407: Tibial Template Size D
• 05055455518391: Tibial Template Size C
• 05055455518384: Tibial Template Size B
• 05055455518377: Tibial Template Size A
• 05055455518339: Femoral Component Inserter / Remover Support - Green
• 05055455518322: Femoral Component Inserter / Remover Support - Blue
• 05055455518315: Femoral Component Inserter / Remover Support - Red
• 05055455518308: Femoral Component Inserter / Remover Support - Yellow.
• 05055455518292: Femoral Component Inserter / Remover
• 05055455518117: Femoral Trial Right, Size 4
• 05055455518032: Femoral Trial Left, Size 4
• 05055455518025: Femoral Trial Left, Size 3