PriMatrix® 607-005-220

GUDID 10381780113416

PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

TEI BIOSCIENCES INC.

Collagen wound matrix dressing

• Primary Device ID: 10381780113416
• NIH Device Record Key: 641d5330-3353-44b3-85cb-6aff06020429
• Commercial Distribution Discontinuation: 2015-10-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PriMatrix®
• Version Model Number: 607-005-220
• Catalog Number: 607-005-220
• Company DUNS: 796253292
• Company Name: TEI BIOSCIENCES 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: true
• 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)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780113416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131286

FDA Product Code

• KGN: DRESSING, WOUND, COLLAGEN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2015-10-21

On-Brand Devices [PriMatrix®]

• 10381780357421: PriMatrix® is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is
• 10381780357414: PriMatrix® is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is
• 10381780357407: PriMatrix® is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is
• 10381780113751: PriMatrix 2:1 Meshed 10x12cm
• 10381780113744: PriMatrix Fenestrated 20x25cm
• 10381780113737: PriMatrix Fenestrated 10x25cm
• 10381780113720: PriMatrix Fenestrated 8x12 cm
• 10381780113713: PriMatrix Fenestrated 5x5 cm
• 10381780113706: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113690: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113683: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113676: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113669: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113652: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113485: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113478: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113461: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113454: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113447: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113430: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113423: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113416: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113409: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113393: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113386: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113379: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113362: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113355: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113348: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113331: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113324: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113300: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113294: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i
• 10381780113317: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided i