Dextile DXT1612AL
GUDID 10884521726543
Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side
SOFRADIM PRODUCTION
Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable| Primary Device ID | 10884521726543 |
| NIH Device Record Key | 08656ce0-a7bc-4ef8-8eb1-c48357891026 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dextile |
| Version Model Number | DXT1612AL |
| Catalog Number | DXT1612AL |
| Company DUNS | 576342646 |
| Company Name | SOFRADIM PRODUCTION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 |
Device Dimensions
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Device Size Text, specify | 0 |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Device Size Text, specify | 0 |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Device Size Text, specify | 0 |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Device Size Text, specify | 0 |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Device Size Text, specify | 0 |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Device Size Text, specify | 0 |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
| Length | 12 Centimeter |
| Width | 16 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
| Special Storage Condition, Specify | Between 0 and 0 *No; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521726543 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192443
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 | 2020-01-20 |
| Device Publish Date | 2020-01-10 |
On-Brand Devices [Dextile]
| 10884521726543 | Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side |
| 10884521726536 | Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side |
| 10884521726529 | Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side |
| 10884521726512 | Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side |
| 10884521726505 | Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side |
| 10884521726499 | Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side |
Trademark Results [Dextile]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DEXTILE 88722711 not registered Live/Pending |
Sofradim Production 2019-12-11 |
 DEXTILE 87249164 not registered Live/Pending |
Sofradim Production 2016-11-28 |
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