Micro Seal Shell WA-1-1025

GUDID B046WA110250

Micro Seal Shell 52mm

SIGNAL MEDICAL CORPORATION

Metallic acetabular liner

• Primary Device ID: B046WA110250
• NIH Device Record Key: 9097b636-f4e8-457d-a250-455b69f5189e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro Seal Shell
• Version Model Number: 52mm
• Catalog Number: WA-1-1025
• 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	B046WA110250 [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