Symbotex SYM1510
GUDID 10884521190375
Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking
SOFRADIM PRODUCTION
Abdominal hernia surgical mesh, composite-polymer| Primary Device ID | 10884521190375 |
| NIH Device Record Key | 976dc9d3-7a3e-4ff1-9033-3215f0a37fd1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Symbotex |
| Version Model Number | SYM1510 |
| Catalog Number | SYM1510 |
| Company DUNS | 576342646 |
| Company Name | SOFRADIM PRODUCTION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | |
| 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
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
| Length | 15 Centimeter |
| Width | 10 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521190375 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131969
FDA Product Code
| FTL | Mesh, surgical, polymeric |
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 | 2020-10-21 |
| Device Publish Date | 2015-10-06 |
On-Brand Devices [Symbotex]
| 10884521190603 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190627 | Composite Mesh,Skirted Monofilament Polyester Mesh with Absorbable Collagen Film |
| 10884521190566 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190542 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190535 | Composite Mesh,Skirted Monofilament Polyester Mesh with Absorbable Collagen Film |
| 10884521190504 | Composite Mesh,Skirted Monofilament Polyester Mesh with Absorbable Collagen Film |
| 10884521190474 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190467 | Composite Mesh,Skirted Monofilament Polyester Mesh with Absorbable Collagen Film |
| 10884521190436 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190412 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190399 | Composite Mesh,Skirted Monofilament Polyester Mesh with Absorbable Collagen Film |
| 10884521190665 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190658 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190641 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190610 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190597 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190573 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190559 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190528 | Composite Mesh, Monofilament Polyester with Absorbable Collagen Film, Pre-placed Sutures and Mar |
| 10884521190429 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190382 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190498 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190443 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521190405 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Mark |
| 10884521593442 | Composite Mesh Monofilament Polyester with Absorbable Collagen Film, Pre-placed Sutures and Mark |
| 10884521593435 | Composite Mesh Monofilament Polyester with Absorbable Collagen Film and Marking. |
| 10884521190634 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190580 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190511 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190481 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190450 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190375 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190368 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
| 10884521190344 | Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking |
Trademark Results [Symbotex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYMBOTEX 85595691 4522508 Live/Registered |
Sofradim Production 2012-04-12 |
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