SILICONE SHEETING

GUDID 00385640033343

SUMMIT MEDICAL, INC.

Silicone-sheet tissue reconstructive material, sterile

• Primary Device ID: 00385640033343
• NIH Device Record Key: 340b1e34-df6f-4fde-8f8e-230ae9755cdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILICONE SHEETING
• Version Model Number: SP-66050
• Company DUNS: 965484699
• Company Name: SUMMIT MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640033343 [Primary]

FDA Product Code

• MDA: Elastomer, Silicone, For Scar Management

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: 2018-03-29
• Device Publish Date: 2017-12-05

On-Brand Devices [SILICONE SHEETING]

• 00385640033367: SP-66150
• 00385640033350: SP-66100
• 00385640033343: SP-66050
• 00385640033336: SP-66025
• 00385640033329: SP-66012
• 00385640000116: SP-65100
• 00385640000109: SP-65000