DuraSorb Monofilament Mesh
GUDID 00860000875943
SURGICAL INNOVATION ASSOCIATES, INC.
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable| Primary Device ID | 00860000875943 |
| NIH Device Record Key | f76c857b-12b3-42bf-976c-91453888be43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DuraSorb Monofilament Mesh |
| Version Model Number | PTM2025 |
| Company DUNS | 117061618 |
| Company Name | SURGICAL INNOVATION ASSOCIATES, 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 | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health | |
| Phone | 872-870-0520 |
| info@sia.health |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Room Temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000875943 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181094
FDA Product Code
| FTL | Mesh, Surgical, Polymeric |
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 | 2022-08-22 |
| Device Publish Date | 2022-08-12 |
On-Brand Devices [DuraSorb Monofilament Mesh]
| 00860000875905 | PTM1025 |
| 00860000875943 | PTM2025 |
| 00860000875929 | PTM0616 |
Trademark Results [DuraSorb Monofilament Mesh]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURASORB MONOFILAMENT MESH 88100341 not registered Live/Pending |
Surgical Innovation Associates, Inc 2018-08-31 |
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