MatriStem PFM0710
GUDID 00386190000854
Pelvic Floor Matrix 7 x 10 cm
ACELL, INC.
Pelvic organ prolapse/stress urinary incontinence surgical mesh| Primary Device ID | 00386190000854 |
| NIH Device Record Key | 7e4796fc-2ec7-41e0-a31b-471bac03a31f |
| Commercial Distribution Discontinuation | 2018-07-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | MatriStem |
| Version Model Number | PFM0710 |
| Catalog Number | PFM0710 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386190000854 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141084
FDA Product Code
| FTM | Mesh, surgical |
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 | 2018-10-29 |
| Device Publish Date | 2017-01-10 |
On-Brand Devices [MatriStem]
| 00386190000922 | Surgical Matrix Plus 5 x 7 cm |
| 00386190000915 | Surgical Matrix Plus 7 x 10 cm |
| 00386190000908 | Surgical Matrix Plus 10 x 10 cm |
| 00386190000892 | Surgical Matrix Plus 10 x 15 cm |
| 00386190000861 | Pelvic Floor Matrix 10 x 15 cm |
| 00386190000854 | Pelvic Floor Matrix 7 x 10 cm |
| 00386190000847 | Pelvic Floor Matrix 5 x 5 cm |
| 00386190000830 | Pelvic Floor Matrix 4 x 12 cm |
| 00386190000823 | Multilayer Wound Matrix 10 X 15 cm |
| 00386190000816 | Multilayer Wound Matrix 7 X 10 cm |
| 00386190000809 | Multilayer Wound Matrix 5 X 5 cm |
| 00386190000786 | Burn Matrix Meshed 10X15cm |
| 00386190000779 | Burn Matrix Meshed 7X10cm |
| 00386190000762 | Burn Matrix Meshed 5X5cm |
| 00386190000533 | Pelvic Floor Matrix 9 x 12 cm |
| 00386190000526 | Surgical Matrix Thick 30 x 40 cm |
| 00386190000519 | Surgical Matrix Thick 30 x 30 cm |
| 00386190000502 | Surgical Matrix Thick 20 x 35 cm |
| 00386190000496 | Surgical Matrix Thick 20 x 30 cm |
| 00386190000489 | Surgical Matrix Thick 20 x 25 cm |
| 00386190000472 | Surgical Matrix Thick 20 x 20 cm |
| 00386190000465 | Surgical Matrix Thick 16 x 20 cm |
| 00386190000458 | Surgical Matrix Thick 10 x 20 cm |
| 00386190000441 | Surgical Matrix 10 x 15 cm |
| 00386190000434 | Surgical Matrix 8 x 16 cm |
| 00386190000427 | Surgical Matrix 6 x 15 cm |
| 00386190000410 | Surgical Matrix 7 x 10 cm |
| 00386190000403 | Surgical Matrix 5 x 5 cm |
| 00386190000397 | Surgical Matrix 4 x 12 cm |
| 00386190000380 | Surgical Matrix Thin 10 x 15 cm |
| 00386190000373 | Surgical Matrix Thin 7 x 15 cm |
| 00386190000366 | Surgical Matrix Thin 4 x 12 cm |
| 00386190000359 | Surgical Matrix Thin 6 x 15 cm |
| 00386190000342 | Surgical Matrix Thin 7 x 10 cm |
| 00386190000335 | Surgical Matrix Thin 5 x 5 cm |
| 00386190000304 | Surgical Matrix RS 10 x 15 cm |
| 00386190000298 | Surgical Matrix RS 8 x 16 cm |
| 00386190000281 | Surgical Matrix RS 6 x 15 cm |
| 00386190000274 | Surgical Matris RS 7 x 10 cm |
| 00386190000267 | Surgical Matrix RS 5 x 5 cm |
| 00386190000250 | Surgical Matrix RS 2 x 4 cm |
| 00386190000229 | MicroMatrix, 1000 mg |
| 00386190000212 | MicroMatrix, 500 mg |
| 00386190000199 | MicroMatrix, 200 mg Fine Particulate |
| 00386190000182 | MicroMatrix, 200 mg |
| 00386190000168 | MicroMatrix, 100 mg Fine Particulate |
| 00386190000151 | MicroMatrix, 100 mg |
| 00386190000137 | MicroMatrix, 60 mg |
| 00386190000113 | MatriStem Wound Sheet, 10 X 15 cm |
| 00386190000090 | MatriStem Wound Sheet, 7 X 10 cm |
Trademark Results [MatriStem]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MATRISTEM 77526850 3632971 Live/Registered |
ACell, Inc. 2008-07-21 |
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