Cytal WSM1015
GUDID 00386190001042
Wound Matrix 2-Layer 10 x 15 cm
ACELL, INC.
Collagen wound matrix dressing| Primary Device ID | 00386190001042 |
| NIH Device Record Key | 46348bcd-b3d1-4ee6-91ec-57f3e37c90c2 |
| Commercial Distribution Discontinuation | 2018-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Cytal |
| Version Model Number | WSM1015 |
| Catalog Number | WSM1015 |
| 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 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
| customerservice@acell.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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386190001042 [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 | 6 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2017-01-10 |
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 |
Trademark Results [Cytal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYTAL 86783355 5196435 Live/Registered |
ACell, Inc. 2015-10-09 |
 CYTAL 72216058 0810734 Dead/Expired |
CUTTER LABORATORIES, INC. 1965-04-08 |
 CYTAL 71678603 0613802 Dead/Cancelled |
CUTTER LABORATORIES 1954-12-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.