ClosureFast
GUDID 20884521140308
Introducer Sheath Set
Covidien LP
General surgical procedure kit, non-medicated, reusable| Primary Device ID | 20884521140308 |
| NIH Device Record Key | 36675c42-84d3-4852-9a45-855f0ff50698 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClosureFast |
| Version Model Number | IS-7F11 |
| 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 | true |
| 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 | true |
| 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 |
Device Dimensions
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
| Length | 11 Centimeter |
| Catheter Gauge | 7 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521140301 [Primary] |
| GS1 | 20884521140308 [Package] Contains: 10884521140301 Package: PACK_OR_INNER_PACK [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K780126
FDA Product Code
| DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
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 | 2021-09-29 |
| Device Publish Date | 2017-05-24 |
On-Brand Devices [ClosureFast]
| 10884521181816 | Procedure Pack |
| 10884521174924 | Endovenous Radiofrequency Ablation (RFA) Catheter,3 cm Heating Element,7 Fr/Ch (2.3 mm) x 60 cm |
| 10884521058071 | Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x 60 cm |
| 10884521058057 | Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x 100 cm |
| 20884521140353 | Micro Introducer Sheath Set |
| 20884521140308 | Introducer Sheath Set |
| 20884521173528 | Introducer Sheath Set |
| 20884521140292 | Micro Introducer Sheath Set |
| 20884521592626 | Guidewire Single Ended, SS, Fixed Core |
| 20884521058122 | Ultrasound Probe Cover,6"" x 96"" (15.2 cm x 2.4 m) |
| 20884521140407 | Tumescent Infiltration Kit |
| 20884521140384 | Micro Puncture Kit |
| 20884521140377 | Micro Puncture Kit |
| 10884521140417 | Tumescent Pump Foot Pedal,Gradual Control |
| 20884521140223 | Guidewire,Single Ended, PTFE, Fixed Core,0.018"" (0.46 mm) x 45 cm |
| 10884521140424 | Tumescent Pump Foot Pedal,On/Off Control |
| 20884521173511 | Arterial Needle,Echogenic Tip,21 G (0.813 mm) x 2.75"" (70 mm) |
| 20884521140261 | Guidewire,Double Ended, PTFE, Fixed Core,0.035"" (0.89 mm) x 45 cm |
| 20884521140254 | Guidewire,J Tip, PTFE, Fixed Core,0.025"" (0.64 mm) x 260 cm |
| 20884521140247 | Guidewire,Double Ended, PTFE, Fixed Core,0.025"" (0.64 mm) x 150 cm |
| 20884521140193 | Arterial Needle,21 G (0.813 mm) x 2.75"" (70 mm) |
| 20884521140186 | Arterial Needle,Ultra Thin Wall with Echogenic Tip,19 G (1.067 mm) x 2.75"" (70 mm) |
| 20884521140179 | Arterial Needle,Ultra Thin Wall,19 G (1.067 mm) x 2.75"" (70 mm) |
| 20884521140209 | Compression Bandages,Cohesive,4"" x 15' (10.16 cm x 4.572 m) |
| 20884521140216 | Compression Bandages,Cohesive,6"" x 15' (15.24 cm x 4.572 m) |
Trademark Results [ClosureFast]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLOSUREFAST 78981195 3738306 Live/Registered |
COVIDIEN LP 2005-11-15 |
 CLOSUREFAST 78754633 not registered Dead/Abandoned |
VNUS Medical Technologies, Inc. 2005-11-15 |
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