Gentrix® MSPL0507
GUDID 00386190001936
Surgical Matrix Plus 5 x 7 cm
ACELL, INC.
Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial| Primary Device ID | 00386190001936 |
| NIH Device Record Key | 0df804be-13c5-45a6-a136-e530e867204a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gentrix® |
| Version Model Number | MSPL0507A |
| Catalog Number | MSPL0507 |
| 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 |
| 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 |
| 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 |
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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 | |
| 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 |
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| Phone | +1(800)826-2926 |
| customerservice@acell.com |
Device Dimensions
| Width | 5 Centimeter |
| Length | 7 Centimeter |
| Width | 5 Centimeter |
| Length | 7 Centimeter |
| Width | 5 Centimeter |
| Length | 7 Centimeter |
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| Length | 7 Centimeter |
| Width | 5 Centimeter |
| Length | 7 Centimeter |
| Width | 5 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386190001936 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182259
FDA Product Code
| OWV | Mesh, surgical, collagen, diaphragmatic hernia |
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 |
Trademark Results [Gentrix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENTRIX 86956739 5297343 Live/Registered |
ACell, Inc. 2016-03-29 |
 GENTRIX 86126669 not registered Dead/Abandoned |
Gentrix 2013-11-22 |
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