Cardion™
GUDID 00386190002063
for Pericardial Repair, 7 x 15 cm
ACELL, INC.
Multi-purpose surgical mesh, collagen, bioabsorbable| Primary Device ID | 00386190002063 |
| NIH Device Record Key | 195ffed8-f309-487e-9602-287b4250671c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardion™ |
| Version Model Number | PP0715 |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | +1(800)826-2926 |
| customerservice@acell.com | |
| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
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| Phone | +1(800)826-2926 |
| customerservice@acell.com |
Device Dimensions
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 Centimeter |
| Length | 15 Centimeter |
| Width | 7 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 |
| 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 | 00386190002063 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191734
FDA Product Code
| PSQ | Intracardiac patch or pledget, biologically derived |
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 | 2020-08-21 |
| Device Publish Date | 2020-08-13 |
On-Brand Devices [Cardion™]
| 00386190002087 | for Pericardial Repair, 10 x 15 cm |
| 00386190002070 | for Pericardial Repair, 7 x 10 cm |
| 00386190002063 | for Pericardial Repair, 7 x 15 cm |
Trademark Results [Cardion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDION 98303963 not registered Live/Pending |
ACell, Inc. 2023-12-07 |
 CARDION 88795790 not registered Live/Pending |
ACell, Inc. 2020-02-13 |
 CARDION 76030932 not registered Dead/Abandoned |
CARDIOGENE GENTHERAPEUTISCHE SYSTEME AG 2000-04-19 |
 CARDION 73038725 1021954 Dead/Expired |
GENERAL SIGNAL CORPORATION 1974-12-05 |
 CARDION 73038724 1021953 Dead/Expired |
GENERAL SIGNAL CORPORATION 1974-12-05 |
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