Cytal BMM1015

GUDID 00386190001110

Burn Matrix 10 x 15 cm

ACELL, INC.

Collagen wound matrix dressing

• Primary Device ID: 00386190001110
• NIH Device Record Key: 080ac35d-e899-4bd9-be9c-f09e7cbbafc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytal
• Version Model Number: BMM1015
• Catalog Number: BMM1015
• Company DUNS: 137258252
• Company Name: ACELL, 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: 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
• 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

• Length: 15 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
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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
• 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	00386190001110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152721

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: 2017-01-20

On-Brand Devices [Cytal]

• 00386190001516: Wound Matrix 6-Layer 10 x 15 cm
• 00386190001509: Wound Matrix 6-Layer 7 x 10 cm
• 00386190001493: Wound Matrix 6-Layer 5 x 5 cm
• 00386190001486: Wound Matrix 3-Layer 10 x 15 cm
• 00386190001479: Wound Matrix 3-Layer 7 x 10 cm
• 00386190001462: Wound Matrix 3-Layer 5 x 5 cm
• 00386190001455: Wound Matrix 2-Layer 10 x 15 cm
• 00386190001448: Wound Matrix 2-Layer 7 x 10 cm
• 00386190001431: Wound Matrix 2-Layer 5 x 5 cm
• 00386190001424: Wound Matrix 1-Layer 10 x 15 cm
• 00386190001417: Wound Matrix 1-Layer 7 x 10 cm
• 00386190001400: Wound Matrix 1-Layer 3 x 7 cm
• 00386190001394: Wound Matrix 1-Layer 3 x 3.5 cm
• 00386190001110: Burn Matrix 10 x 15 cm
• 00386190001103: Burn Matrix 7 x 10 cm
• 00386190001097: Burn Matrix 5 x 5 cm
• 00386190001080: Wound Matrix 1- Layer 10 x 15 cm
• 00386190001073: Wound Matrix 1- Layer 7 x 10 cm
• 00386190001066: Wound Matrix 1- Layer 3 x 7 cm
• 00386190001059: Wound Matrix 1- Layer 3 x 3.5 cm
• 00386190001042: Wound Matrix 2-Layer 10 x 15 cm
• 00386190001035: Wound Matrix 2-Layer 7 x 10 cm
• 00386190001028: Wound Matrix 2-Layer 5 x 5 cm
• 00386190001011: Burn Matrix 5 X 5 cm
• 00386190001004: Burn Matrix 7 X 10 cm
• 00386190000991: Burn Matrix 10 X 15 cm
• 00386190000984: Wound Matrix 6-Layer 10 x 15 cm
• 00386190000977: Wound Matrix 6-Layer 7 x 10 cm
• 00386190000960: Wound Matrix 6-Layer 5 x 5 cm
• 00386190000953: Wound Matrix 3-Layer 10 x 15 cm
• 00386190000946: Wound Matrix 3-Layer 7 x 10 cm
• 00386190000939: Wound Matrix 3-Layer 5 x 5 cm