Gentrix® PSMX1015

GUDID 00386190001875

Surgical Matrix 10 x 15 cm

ACELL, INC.

Multi-purpose surgical mesh, collagen, bioabsorbable

• Primary Device ID: 00386190001875
• NIH Device Record Key: e8054366-94d8-42a5-bdc7-d6b4064fb935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentrix®
• Version Model Number: PSMX1015A
• Catalog Number: PSMX1015
• Company DUNS: 137258252
• Company Name: ACELL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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)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
• 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
• 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
• 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
• 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
• 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 Dimensions

• Width: 10 Centimeter
• Length: 15 Centimeter
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• Length: 15 Centimeter
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• Length: 15 Centimeter
• Width: 10 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry environment at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386190001875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182259

FDA Product Code

• OXH: Mesh, surgical, collagen, plastic and reconstructive surgery

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: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [Gentrix®]

• 00386190001813: Surgical Matrix Thick 10 x 20 cm
• 00386190001790: Surgical Matrix Thick 16 x 20 cm
• 00386190001783: Surgical Matrix Thick 16 x 40 cm
• 00386190001776: Surgical Matrix Thick 16 x 30 cm
• 00386190001769: Incisional Matrix 6 x 15 cm
• 00386190001752: Incisional Matrix 4 x 15 cm
• 00386190001745: Incisional Matrix 4 x 10 cm
• 00386190001738: Incisional Matrix 4 x 6 cm
• 00386190001967: Surgical Matrix Plus 10 x 15 cm
• 00386190001950: Surgical Matrix Plus 10 x 10 cm
• 00386190001943: Surgical Matrix Plus 7 x 10 cm
• 00386190001936: Surgical Matrix Plus 5 x 7 cm
• 00386190001929: Surgical Matrix Thin 10 x 15 cm
• 00386190001912: Surgical Matrix Thin 7 x 15 cm
• 00386190001905: Surgical Matrix Thin 7 x 10 cm
• 00386190001899: Surgical Matrix Thin 6 x 15 cm
• 00386190001882: Surgical Matrix Thin 4 x 12 cm
• 00386190001875: Surgical Matrix 10 x 15 cm
• 00386190001868: Surgical Matrix Thin 5 x 5 cm
• 00386190001851: Surgical Matrix 7 x 10 cm
• 00386190001844: Surgical Matrix 5 x 5 cm
• 00386190001592: Surgical Matrix Hiatal 7.5 x 6 cm
• 00386190002698: Surgical Matrix Thick 10 x 20 cm
• 00386190002681: Surgical Matrix Thick 16 x 20 cm