TCC-EZ® TCC2SAW

GUDID 00809958000366

TOTAL CONTACT CAST SYSTEM - Cast Removal Saw.

Derma Sciences Canada Inc

Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade Cast cutter blade

• Primary Device ID: 00809958000366
• NIH Device Record Key: 8ae0e210-6923-4e06-994f-5db106f580a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TCC-EZ®
• Version Model Number: TCC2SAW
• Catalog Number: TCC2SAW
• Company DUNS: 200564891
• Company Name: Derma Sciences Canada 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com
• Phone: +1(800)826-2926
• Email: customerservice@acell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00809958000366 [Primary]

FDA Product Code

• LGH: INSTRUMENT, CAST REMOVAL, AC-POWERED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-23
• Device Publish Date: 2018-10-23

On-Brand Devices [TCC-EZ®]

• 00809958010112: TOTAL CONTACT CAST SYSTEM - MedE-Kast Ultra - Single Application
• 00809958010013: TOTAL CONTACT CAST SYSTEM - MedE-Kast Ultra - 10 Casting Systems
• 00809958009819: TOTAL CONTACT CAST SYSTEM - MedE-Kast - 10 Casting Systems
• 00809958009710: TOTAL CONTACT CAST SYSTEM - Large TMA Boot
• 00809958009215: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 2 Large Boots
• 00809958009116: 4" Rolls of Fiberclass (10 rolls)
• 00809958009017: 3" Rolls of Fiberglass (10 rolls)
• 00809958007419: TOTAL CONTACT CAST SYSTEM - 5 Casting Systems, 5-3" and 5-4" with NO boots
• 00809958007310: TOTAL CONTACT CAST SYSTEM - 5 Casting Systems, 5-3" and 5-4" with regular boots
• 00809958007211: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 2 Extra Large Boots
• 00809958007112: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 2 Large Boots
• 00809958007013: TOTAL CONTACT CAST SYSTEM - 5 Casting Systems, without Boot
• 00809958006818: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 1 Extra Large Boot
• 00809958006719: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 1 Large Charcot Boot
• 00809958006610: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 1 Large Boot
• 00809958006412: TOTAL CONTACT CAST SYSTEM - 5 Casting Systems, 1 Regular Boot
• 00809958006115: TOTAL CONTACT CAST SYSTEM - 1 Casting System
• 00809958006016: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems
• 00809958005910: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 2 Regular Boots
• 00809958005811: TOTAL CONTACT CAST SYSTEM - 5 Casting Systems
• 00809958005613: TOTAL CONTACT CAST SYSTEM - 5 Casting Systems, 1 Regular Boot
• 00809958005316: TOTAL CONTACT CAST SYSTEM - 1 Casting System
• 00809958005217: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems
• 00809958005118: TOTAL CONTACT CAST SYSTEM - 10 Casting Systems, 2 Regular Boots
• 00809958005019: TOTAL CONTACT CAST SYSTEM - Extra Large Charcot Boot
• 00809958004913: TOTAL CONTACT CAST SYSTEM - Extra Large Boot
• 00809958004814: TOTAL CONTACT CAST SYSTEM -Large Charcot Boot
• 00809958004715: TOTAL CONTACT CAST SYSTEM - Large Boot
• 00809958004616: TOTAL CONTACT CAST SYSTEM - Regular Boot
• 00809958000373: TOTAL CONTACT CAST SYSTEM - Cast Removal Saw Replacement Stell Blades.
• 00809958000366: TOTAL CONTACT CAST SYSTEM - Cast Removal Saw.
• 00809958000076: TOTAL CONTACT CAST SYSTEM - MedE-Kast GSII - 10 Casting Systems