Instrument IMGENIMP

GUDID 05060296233839

General Impactor

Stanmore Implants Worldwide Ltd

Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable Orthopaedic implant impactor, reusable

• Primary Device ID: 05060296233839
• NIH Device Record Key: 657a72d3-c988-4f9e-8151-5bc0ef066ea8
• Commercial Distribution Discontinuation: 2023-06-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Instrument
• Version Model Number: imgenimp
• Catalog Number: IMGENIMP
• Company DUNS: 494989502
• Company Name: Stanmore Implants Worldwide 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: false
• 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	05060296233839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092138

FDA Product Code

• KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

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

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

[05060296233839]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-06-05
• Device Publish Date: 2019-07-18

On-Brand Devices [Instrument]

• 05060296236328: Passive Hinge Reamer STD
• 05060296236311: Passive Hinge Reamer SM
• 05060296236304: Passive Hinge Reamer XSM
• 05060296236175: Rotating Hinge Polyethylene Reamer: Extra-Small
• 05060296236151: Rotating Hinge Metal-Cased Reamer: Extra-Small
• 05060296233860: Rotating Hinge Polyethylene Reamer: Standard
• 05060296233846: Rotating Hinge Polyethylene Reamer: Small
• 05060296233778: Rotating Hinge Metal-Cased Reamer: Small
• 05060296233761: Rotating Hinge Metal-Cased Reamer: Standard
• 05060296233709: Fixed hinge Reamer
• 05060296236489: Customs Tibial Cutting Guide Lid
• 05060296236472: Customs Tibial Cutting Guide Tray
• 05060296236465: Insert - Extra Small Customs Tray
• 05060296236458: Base - Extra Small Customs Tray
• 05060296236441: Insert - Small Customs Tray
• 05060296236434: Base - Small Customs Tray
• 05060296236427: Common Lid - Transparent
• 05060296236410: Insert - Standard Customs Tray
• 05060296236403: Base - Standard Customs Tray
• 05060296236250: Trial Axle STD
• 05060296236243: Trial Axle SM
• 05060296236236: Trial Axle XSM
• 05060296236229: Trial Tibial Plateau Plate: 20mm Extra-Small
• 05060296236212: Trial Tibial Plateau Plate: 15mm Extra-Small
• 05060296236205: Trial Tibial Plateau Plate: 10mm Extra-Small
• 05060296236199: Trial Tibial Plateau Plate: 5mm Extra-Small
• 05060296234430: Trial Tibial Plateau Plate: 20mm Small
• 05060296234423: Trial Tibial Plateau Plate: 15mm Small
• 05060296234416: Trial Tibial Plateau Plate: 10mm Small
• 05060296234409: Trial Tibial Plateau Plate: 5mm Small
• 05060296234393: Trial Tibial Plateau Plate: 5mm Standard
• 05060296234386: Trial Tibial Plateau Plate: 10mm Standard
• 05060296234379: Trial Tibial Plateau Plate: 15mm Standard
• 05060296234362: Trial Tibial Plateau Plate: 20mm Standard
• 05060296236380: Axle cap introducer
• 05060296236373: Passive EXSM Positioning Plate: Slots
• 05060296236366: Passive SM Positioning Plate: Slots
• 05060296236359: Passive STD Positioning Plate: Slots
• 05060296236342: EXSM Positioning Plate: Slots
• 05060296236335: EXSM Positioning Plate: Holes
• 05060296236168: Cutting Guide Fixation Pin
• 05060296236137: Bush Compressor: Extra-Small
• 05060296236120: Face Cutter Body & Spigot
• 05060296236113: Alignment Tool 50, 70, & 90mm
• 05060296233822: Tibial Cutting Guide: Prongs
• 05060296233815: Tibial Cutting Guide: Rest
• 05060296233808: Tibial Cutting Guide: Rod
• 05060296233747: STD Positioning Plate: Slots
• 05060296233730: STD Positioning Plate: Holes
• 05060296233723: SM Positioning Plate: Slots