Sofsilk GS451-2
GUDID 20884521758091
Wax Coated Braided Silk
Covidien LP
Silk suture, sterile| Primary Device ID | 20884521758091 |
| NIH Device Record Key | 281e6916-7573-4b43-8b21-99670b6ece8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sofsilk |
| Version Model Number | GS451-2 |
| Catalog Number | GS451-2 |
| 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 |
| 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
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
| Length | 30 Inch |
| Device Size Text, specify | 0 |
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; |
| 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; |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521758094 [Primary] |
| GS1 | 20884521758091 [Package] Contains: 10884521758094 Package: CASE [36 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K981128
FDA Product Code
| GAP | SUTURE, NONABSORBABLE, SILK |
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 | 2020-02-06 |
| Device Publish Date | 2020-01-29 |
On-Brand Devices [Sofsilk]
| 10884521126909 | Silk Single Stitch Reload |
| 10884521126855 | Silk Single Stitch Reload |
| 10884521126848 | Silk Single Stitch Reload |
| 20884521089188 | Wax Coated Braided Silk |
| 20884521086095 | Wax Coated Braided Silk |
| 20884521091129 | Wax Coated Braided Silk |
| 20884521091105 | Wax Coated Braided Silk |
| 20884521085876 | Wax Coated Braided Silk |
| 20884521085760 | Wax Coated Braided Silk |
| 20884521085623 | Wax Coated Braided Silk |
| 20884521091037 | Wax Coated Braided Silk |
| 20884521182346 | Wax Coated Braided Silk,HGS-23,(5),D-Tach,5x Black Strands |
| 20884521165691 | Wax Coated Braided Silk,GS-18,D/A,1x Black Strand |
| 20884521133447 | Wax Coated Braided Silk,SK,1x Black Strand |
| 20884521106113 | Wax Coated Braided Silk |
| 20884521106106 | Wax Coated Braided Silk |
| 20884521106090 | Wax Coated Braided Silk |
| 20884521106052 | Wax Coated Braided Silk |
| 20884521106038 | Wax Coated Braided Silk |
| 20884521106021 | Wax Coated Braided Silk |
| 20884521091099 | Wax Coated Braided Silk |
| 20884521087719 | Wax Coated Braided Silk |
| 20884521086675 | Wax Coated Braided Silk |
| 20884521086408 | Wax Coated Braided Silk |
| 20884521086354 | Wax Coated Braided Silk |
| 20884521086156 | Wax Coated Braided Silk |
| 20884521086149 | Wax Coated Braided Silk |
| 20884521085982 | Wax Coated Braided Silk |
| 20884521085715 | Wax Coated Braided Silk |
| 20884521085616 | Wax Coated Braided Silk |
| 20884521085395 | Wax Coated Braided Silk |
| 20884521085142 | Wax Coated Braided Silk |
| 20884521084770 | Wax Coated Braided Silk |
| 20884521084756 | Wax Coated Braided Silk |
| 20884521176406 | Wax Coated Braided Silk,P-24,1x Black Strand |
| 20884521163819 | Wax Coated Braided Silk |
| 20884521163802 | Wax Coated Braided Silk |
| 20884521138428 | Wax Coated Braided Silk |
| 20884521106076 | Wax Coated Braided Silk |
| 20884521106014 | Wax Coated Braided Silk |
| 20884521086637 | Wax Coated Braided Silk |
| 20884521086453 | Wax Coated Braided Silk |
| 20884521086170 | Wax Coated Braided Silk |
| 20884521086019 | Wax Coated Braided Silk |
| 20884521085951 | Wax Coated Braided Silk |
| 20884521085746 | Wax Coated Braided Silk |
| 20884521085463 | Wax Coated Braided Silk |
| 20884521758121 | Wax Coated Braided Silk |
| 20884521758107 | Wax Coated Braided Silk |
| 20884521758091 | Wax Coated Braided Silk |
Trademark Results [Sofsilk]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFSILK 74002125 1661283 Live/Registered |
UNITED STATES SURGICAL CORPORATION 1989-11-16 |
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