Symbotex SYM12F
GUDID 10884521190351
Composite Mesh, Monofilament Polyester with Absorbable Collagen Film, Pre-placed Sutures and Marking.
Covidien LP
Abdominal hernia surgical mesh, composite-polymer| Primary Device ID | 10884521190351 |
| NIH Device Record Key | d1ca15fd-00c3-42a6-abac-27981ca3ea9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Symbotex |
| Version Model Number | SYM12F |
| Catalog Number | SYM12F |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
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| 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 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| Phone | +1(508)261-8000 |
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| 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
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| Outer Diameter | 12 Centimeter |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521190351 [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 | 2016-04-15 |
Devices Manufactured by Covidien LP
| 10884521700710 - Situate | 2025-04-14 Extremity Scanner For use with the Situate Detection Console 200X |
| 20884521751054 - Valleylab | 2025-04-14 Valleylab Biopolar Forceps Cord, Non-Sterile Bulk |
| 10884521705265 - RF Assure | 2025-04-08 RF Assure Detection System Console Model 200 Refurbished |
| 20884521038964 - Valleylab | 2025-04-04 Valleylab Suction Coagulator 10FR/CH (3.33mm), 6" (15.24 cm) Non-Sterile Bulk |
| 20884521033129 - Valleylab | 2025-03-24 Laparoscopic Handset Four-Function Non-Sterile Bulk;Caution: For manufacturing, processing, or repacking |
| 30884522020279 - DAR | 2025-03-18 Catheter Mount |
| 10884522034753 - DAR | 2025-03-18 Catheter Mount Extendable |
| 10884522034791 - DAR | 2025-03-18 Catheter Mount Extendable |
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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