Micro Seal Shell WA-1-1022

GUDID B046WA110220

Micro Seal Shell 46mm

SIGNAL MEDICAL CORPORATION

Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner Metallic acetabular liner

• Primary Device ID: B046WA110220
• NIH Device Record Key: 7388136c-2b7e-472a-a156-676dab98da01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro Seal Shell
• Version Model Number: 46mm
• Catalog Number: WA-1-1022
• Company DUNS: 169289308
• Company Name: SIGNAL MEDICAL CORPORATION
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com
• Phone: 810-364-7070
• Email: jgorney@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B046WA110220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971718

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-12

On-Brand Devices [Micro Seal Shell]

• B046WA110320: Micro Seal Shell 66mm
• B046WA110310: Micro Seal Shell 64mm
• B046WA110300: Micro Seal Shell 62mm
• B046WA110290: Micro Seal Shell 60mm
• B046WA110280: Micro Seal Shell 58mm
• B046WA110270: Micro Seal Shell 56mm
• B046WA110260: Micro Seal Shell 54mm
• B046WA110250: Micro Seal Shell 52mm
• B046WA110240: Micro Seal Shell 50mm
• B046WA110230: Micro Seal Shell 48mm
• B046WA110220: Micro Seal Shell 46mm
• B046WA11021: Micro Seal Shell 44mm
• B046WA11020: Micro Seal Shell 42mm