XTAC

GUDID 00810805000194

For temporary bridging of fascial defects where primary closure is not possible, including but not limited to, abdominal compartment syndrome.

PRESERVATION SOLUTIONS INC

Negative-pressure wound therapy open-abdomen dressing

• Primary Device ID: 00810805000194
• NIH Device Record Key: 32968c22-ce3d-4fa5-89a3-9d231fee8bde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XTAC
• Version Model Number: XTAC
• Company DUNS: 090266979
• Company Name: PRESERVATION SOLUTIONS 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2627236715
• Email: brader@preservationsolutions.com
• Phone: 2627236715
• Email: brader@preservationsolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810805000194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061934

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

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: 2016-10-22

Devices Manufactured by PRESERVATION SOLUTIONS INC

• 00810805000224 - StarGuard Suture Retention Plates - 7": 2019-01-07 For the temporary, external anchoring of sutures and prevention of suture pull through.
• 00810805000231 - StarGuard Suture Retention Plates - 9": 2019-01-07 For the temporary, external anchoring of sutures and prevention of suture pull through.
• 10810805000092 - Belzer MPS (UW Machine Perfusion Solution ): 2018-07-06 Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL
• 10810805000108 - Belzer MPS (UW Machine Perfusion Solution ): 2018-07-06 Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL
• 10810805000177 - Waters IGL Pulsatile Perfusion Solution: 2018-07-06 Formulated for the in-vitro flushing and continuous hypothermic machine perfusion preservation of explanted kidneys. 1000 mL
• 00810805000187 - Wittmann Patch: 2018-07-06 For temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are nece
• 00810805000194 - XTAC: 2018-07-06For temporary bridging of fascial defects where primary closure is not possible, including but not limited to, abdominal compartment syndrome.
• 00810805000194 - XTAC: 2018-07-06 For temporary bridging of fascial defects where primary closure is not possible, including but not limited to, abdominal compart
• 10810805000023 - Belzer UW Cold Storage Solution: 2018-03-29 Formulated for flushing and cold storage of kidney, liver and pancreas organs. 500 mL