DERMACLOSE 580110000011

GUDID 00844735006216

Continuous External Tissue Expander

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Skin-closing tension device

• Primary Device ID: 00844735006216
• NIH Device Record Key: 4f252ac0-2959-472b-8171-b3393cb7f02c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DERMACLOSE
• Version Model Number: GEM204010-K
• Catalog Number: 580110000011
• Company DUNS: 031284586
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: +1(800)510-3318
• Email: smca_information@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844735006216 [Primary]

FDA Product Code

• MKY: SYSTEM, SKIN CLOSURE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-17
• Device Publish Date: 2020-04-09

On-Brand Devices [DERMACLOSE]

• 00844735006131: DERMACLOSE XL is a continuous external tissue expander for rapid tissue movement to reduce or re
• 00844735006124: DERMACLOSE is a continuous external tissue expander for rapid tissue movement to reduce or reapp
• 00844735006223: Continuous External Tissue Expander
• 00844735006216: Continuous External Tissue Expander
• 00844735006735: DERMACLOSE (95CM) US-APAC
• 00844735006728: DERMACLOSE (66CM) US-APAC