Syneture
GUDID 20884521762562
Absorbable Wound Closure Device
Covidien LP
Polyester suture, non-bioabsorbable, monofilament| Primary Device ID | 20884521762562 |
| NIH Device Record Key | bab5f301-2c47-47e1-9eae-dfc6a71ebbdf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Syneture |
| Version Model Number | VLOCN2145 |
| 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 | false |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
| Device Size Text, specify | 0 |
| Length | 9 Inch |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521762565 [Primary] |
| GS1 | 20884521762562 [Package] Contains: 10884521762565 Package: CASE [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103052
FDA Product Code
| GAT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE |
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 | 2021-01-29 |
| Device Publish Date | 2018-03-21 |
On-Brand Devices [Syneture]
| 10884521725515 | (1) CL-830, (1) CL-904, (3) CL-905, (2) CN-792 |
| 10884521189560 | Custom Suture Pack |
| 20884521780931 | Coated Braided Synthetic Absorbable Suture |
| 20884521160924 | Custom Suture Pack |
| 20884521160863 | Custom Suture Pack |
| 20884521159485 | Custom Suture Pack |
| 20884521581194 | Custom Suture Pack, (1) 88862589-63, (2) 88863086-56, (4) GS-832, (2) VLOCM0024, (2) VP-556-X, ( |
| 20884521581187 | Custom Suture Pack, (2) 88862589-63, (2) 88863324-56, (4) GS-832, (2) VLOCM0024, (2) VP-521-X, ( |
| 20884521581170 | Custom Suture Pack, (2) 88862589-63, (2) 88863324-56, (4) GS-832, (2) VLOCM0024, (2) VP-521-X, ( |
| 20884521196879 | Custom Suture Pack |
| 20884521196831 | Custom Suture Pack |
| 20884521196169 | Custom Suture Pack |
| 20884521178790 | Custom Suture Pack |
| 20884521175904 | Custom Suture Pack |
| 20884521174860 | Custom Suture Pack |
| 20884521161617 | Custom Suture Pack |
| 20884521161600 | Custom Suture Pack |
| 20884521161525 | Custom Suture Pack |
| 20884521161471 | Custom Suture Pack |
| 20884521160986 | Custom Suture Pack |
| 20884521160962 | Custom Suture Pack |
| 20884521160641 | Custom Suture Pack |
| 20884521160450 | Custom Suture Pack |
| 20884521160443 | Custom Suture Pack |
| 20884521160436 | Custom Suture Pack |
| 20884521160429 | Custom Suture Pack |
| 20884521160344 | Custom Suture Pack |
| 20884521160306 | Custom Suture Pack |
| 20884521160283 | Custom Suture Pack |
| 20884521160269 | Custom Suture Pack |
| 20884521160191 | Custom Suture Pack |
| 20884521160061 | Custom Suture Pack |
| 20884521160009 | Custom Suture Pack |
| 20884521159492 | Custom Suture Pack |
| 20884521159461 | Custom Suture Pack |
| 20884521159430 | Custom Suture Pack |
| 20884521159423 | Custom Suture Pack |
| 20884521159379 | Custom Suture Pack |
| 20884521159317 | Custom Suture Pack |
| 20884521159256 | Custom Suture Pack |
| 20884521780238 | PBT Non-Absorbable Wound Closure Device |
| 20884521781495 | Custom Suture Pack, (1) 8886318551, (3) 8886325651, (4) CL903, (2) CL905, (1) S317, (1) S318, (1 |
| 20884521781488 | Custom Suture Pack, (1) 8886199862, (2) 8886261553, (2) 8886261753, (1) 8886325651, (2) 88863271 |
| 20884521766058 | Braided Absorbable Suture |
| 20884521174853 | Custom Suture Pack |
| 20884521593180 | Custom Suture Pack, (2) 88863084-56, (3) GS-62-M, (2) S-184, (2) S-185, (2) S-608, (4) SS-680, ( |
| 20884521160153 | Custom Suture Pack |
| 20884521794563 | Custom Suture Pack, (2) CL924, (2) CS9M, (1) S183, (1) S317, (2) SM5627, (1) SS678, (1) UL215, ( |
| 20884521785790 | Custom Suture Pack, (1) 8886309071, (2) 8886320551, (4) 8886320561, (2) 8886339571 |
| 20884521785783 | Custom Suture Pack, (1) 8886288051, (2) 8886312551, (1) 8886322156 |
Trademark Results [Syneture]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNETURE 76476546 2917771 Dead/Cancelled |
Tyco Healthcare Group LP 2002-12-10 |
 SYNETURE 76474814 2909103 Live/Registered |
COVIDIEN LP 2002-12-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.