Permacol P151828
GUDID 10884523000191
Surgical Implant
SOFRADIM PRODUCTION
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 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 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 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 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 | 10884523000191 |
| NIH Device Record Key | bfdc6601-a94f-4cd7-b813-eea0f9a2b04d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Permacol |
| Version Model Number | P151828 |
| Catalog Number | P151828 |
| Company DUNS | 576342646 |
| Company Name | SOFRADIM PRODUCTION |
| 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 | false |
| 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(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
| Depth | 1.5 Millimeter |
| Width | 18 Centimeter |
| Length | 28 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 100 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884523000191 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120605
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 | 2022-06-10 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [Permacol]
| 10884523000573 | Collagen Repair Patch |
| 10884523000566 | Collagen Repair Patch |
| 10884523000153 | Surgical Implant |
| 10884523000146 | Surgical Implant |
| 10884523000238 | Surgical Implant |
| 10884523000214 | Surgical Implant |
| 10884523000177 | Surgical Implant |
| 10884523000160 | Surgical Implant |
| 10884523000139 | Surgical Implant |
| 10884523000122 | Surgical Implant |
| 10884523000115 | Surgical Implant |
| 10884523000108 | Surgical Implant |
| 10884523000092 | Surgical Implant |
| 10884523000085 | Surgical Implant |
| 10884523000078 | Surgical Implant |
| 10884523000061 | Surgical Implant |
| 10884523000054 | Surgical Implant |
| 10884523000047 | Surgical Implant |
| 10884523000023 | Surgical Implant |
| 10884523000245 | Surgical Implant |
| 10884523000221 | Surgical Implant |
| 10884523000207 | Surgical Implant |
| 10884523000191 | Surgical Implant |
| 10884523000184 | Surgical Implant |
| 10884523000016 | Surgical Implant |
Trademark Results [Permacol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERMACOL 76405739 2780496 Dead/Cancelled |
Paul Hartmann AG 2002-05-10 |
 PERMACOL 75587937 2654649 Live/Registered |
COVIDIEN AG 1998-11-13 |
 PERMACOL 72015862 0648764 Dead/Expired |
W. H. & L. D. BETZ (PARTNERSHIP) 1956-09-18 |
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