ACell® PFM0412
GUDID 00386190001257
Pelvic Floor Matrix 4 x 12 cm
ACELL, INC.
Pelvic organ prolapse/stress urinary incontinence surgical mesh| Primary Device ID | 00386190001257 |
| NIH Device Record Key | 7509c316-827c-48fe-8b7a-32be132db253 |
| Commercial Distribution Discontinuation | 2018-07-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ACell® |
| Version Model Number | PFM0412 |
| Catalog Number | PFM0412 |
| 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 |
Device Dimensions
| Length | 12 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 Centimeter |
| Width | 4 Centimeter |
| Length | 12 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386190001257 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141084
FDA Product Code
| OXH | Mesh, surgical, collagen, plastic and reconstructive surgery |
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 | 2017-01-20 |
On-Brand Devices [ACell®]
| 00386190001295 | Pelvic Floor Matrix 10 x 15 cm |
| 00386190001288 | Pelvic Floor Matrix 9 x 12 cm |
| 00386190001271 | Pelvic Floor Matrix 7 x 10 cm |
| 00386190001264 | Pelvic Floor Matrix 5 x 5 cm |
| 00386190001257 | Pelvic Floor Matrix 4 x 12 cm |
Trademark Results [ACell]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACELL 78155813 2899342 Live/Registered |
Acell, Inc. 2002-08-20 |
 ACELL 78155781 2899341 Live/Registered |
Acell, Inc. 2002-08-20 |
 ACELL 77861361 not registered Dead/Abandoned |
Fooyin University Hospital 2009-10-30 |
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