DERMACLOSE 580100001010

GUDID 00844735006124

DERMACLOSE is a continuous external tissue expander for rapid tissue movement to reduce or reapproximate wounds. After initial use, the device does not require added tightening. Depending on the location and size of the wound, one or more DERMACLOSE may be used for hours - days providing tissue expansion. After expansion, remove device and suture or staple the wound closed

SYNOVIS MICRO COMPANIES ALLIANCE, INC

Skin-closing tension device

• Primary Device ID: 00844735006124
• NIH Device Record Key: 11c268be-77d1-49bc-a01c-8b84ecf038d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DERMACLOSE
• Version Model Number: GEM204010-K
• Catalog Number: 580100001010
• Company DUNS: 031284586
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC
• 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: 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)933-0303
• Email: MEDINFO_MEDPRODUCTS@BAXTER.COM

Device Dimensions

• Length: 66 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844735006124 [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: 2019-04-22
• Device Publish Date: 2019-04-12

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