One-Tie LR-OTE-N
GUDID 10827002319292
One-Tie Compression Coil
Cook Vandergrift Inc.
Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap Pacing/defibrillation lead extraction wrap| Primary Device ID | 10827002319292 |
| NIH Device Record Key | 056bbddd-450a-4ecf-af9a-7492af07ff37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | One-Tie |
| Version Model Number | G31929 |
| Catalog Number | LR-OTE-N |
| Company DUNS | 056867526 |
| Company Name | Cook Vandergrift Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002319295 [Primary] |
| GS1 | 10827002319292 [Package] Contains: 00827002319295 Package: Each [5 Units] In Commercial Distribution |
FDA Product Code
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
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 | 2023-07-14 |
| Device Publish Date | 2023-07-06 |
Devices Manufactured by Cook Vandergrift Inc.
| 10827002583419 - Cook | 2023-11-24 Pin Vise Polymer |
| 00827002200012 - Sof-Grip Hemostat | 2023-07-14 Sof-Grip Hemostat |
| 00827002200036 - Lead Clippers | 2023-07-14 Lead Clippers |
| 00827002200050 - Coil Expander | 2023-07-14 Coil Expander |
| 10827002319292 - One-Tie | 2023-07-14One-Tie Compression Coil |
| 10827002319292 - One-Tie | 2023-07-14 One-Tie Compression Coil |
| 00827002465428 - Bulldog | 2023-07-14 Bulldog Lead Extender |
| 00827002554580 - Cook | 2020-02-06 Charger For Blood Flow Monitor - DP-M350 - Non-Sterile |
| 00827002213630 - Cook-Swartz | 2018-09-12 Cook-Swartz Doppler Flow Probe Standard Cuff |
Trademark Results [One-Tie]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONE-TIE 85737776 4534283 Live/Registered |
Cook Medical Technologies LLC 2012-09-25 |
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