Stanmore SMBSH01

GUDID 05060296232009

Bushes SM

Stanmore Implants Worldwide Ltd

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 05060296232009
• NIH Device Record Key: c79edd63-32cf-4a1d-9abd-76bdf791571c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stanmore
• Version Model Number: Smbsh01
• Catalog Number: SMBSH01
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060296232009 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-07-18

On-Brand Devices [Stanmore]

• 05060296233167: Bumper Pad XSM
• 05060296233150: Bushes XSM
• 05060296233136: Axle Cap
• 05060296232825: Tibial Rotating Hinge Passive Bearing SM
• 05060296232818: Tibial Rotating Hinge Passive Bearing XSM
• 05060296232023: Circlip
• 05060296232016: Bushes STD
• 05060296232009: Bushes SM
• 05060296231996: Bumper Pad STD
• 05060296231989: Bumper Pad SM
• 05060296236106: JTS Distal Femur Left STD
• 05060296236090: JTS Distal Femur Left SM
• 05060296236083: JTS Distal Femur Left XSM
• 05060296236076: JTS Distal Femur Right STD
• 05060296236069: JTS Distal Femur Right SM
• 05060296236052: JTS Distal Femur Right XSM
• 05060296232832: Tibial Rotationg Hinge Passive Bearing STD
• 05060296235970: Tibial Rotating Hinge Metal Cased Bearing XSM
• 05060296232849: Tibial Rotating Hinge Poly Cased Bearing XSM
• 05060296232061: Tibial Rotating Hinge Poly Cased Bearing STD
• 05060296232054: Tibial Rotating Hinge Poly Cased Bearing SM
• 05060296232047: Tibial Rotating Hinge Metal Cased Bearing STD
• 05060296232030: Tibial Rotating Hinge Metal Cased Bearing SM
• 05060296230340: Tibial Plateau Plate STD 20mm
• 05060296230333: Tibial Plateau Plate STD 15mm
• 05060296230326: Tibial Plateau Plate STD 10mm
• 05060296230319: Tibial Plateau Plate STD 5mm
• 05060296230302: Tibial Plateau Plate SM 20mm
• 05060296230296: Tibial Plateau Plate SM 15mm
• 05060296230289: Tibial Plateau Plate SM 10mm
• 05060296230272: Tibial Plateau Plate SM 5mm