ClosureFast™ Micro Introducer Sheath Set MIS-6F11
GUDID 20886333226928
ClosureFast™ Micro Introducer Sheath Set 6 Fr/Ch (2.0mm) x 11cm
ARGON MEDICAL DEVICES, INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 20886333226928 |
| NIH Device Record Key | e7d9d44b-b1b4-422c-ba3a-db0280d25710 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClosureFast™ Micro Introducer Sheath Set |
| Version Model Number | MIS-6F11 |
| Catalog Number | MIS-6F11 |
| Company DUNS | 140727624 |
| Company Name | ARGON MEDICAL DEVICES, INC. |
| 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 | 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
Device Dimensions
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| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333226924 [Primary] |
| GS1 | 10886333226921 [Package] Contains: 00886333226924 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 20886333226928 [Package] Contains: 00886333226924 Package: Box [50 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-31 |
| Device Publish Date | 2022-03-23 |
Devices Manufactured by ARGON MEDICAL DEVICES, INC.
| 20886333227659 - Transfermoral Transcaval Liver Biopsy System | 2024-08-20 Transfermoral Transcaval Liver Biopsy System |
| 20886333227499 - ClosureFast Guidewire | 2024-08-06 ClosureFast™ Guidewire J Tip, PTFE, Fixed Core, 0.025" (0.64mm) x 260cm |
| 20886333227505 - ClosureFast Guidewire | 2024-08-06 ClosureFast™ Guidewire Double Ended, PTFE, Fixed Core 0.035" (0.89mm) x 45cm |
| 20886333227512 - ClosureFast Introducer Sheath | 2024-08-06 ClosureFast Introducer Sheath Set 7Fr/Ch (2.3mm) x 7cm |
| 20886333227529 - ClosureFast Introducer Sheath | 2024-08-06 ClosureFast™ Introducer Sheath Set 7Fr/Ch (2.3mm) x 11cm |
| 20886333227550 - ClosureFast Micro Puncture | 2024-08-06 ClosureFast™ Micro Puncture Kit 4Fr/Ch (1.3mm) |
| 20886333227567 - ClosureFast Micro Puncture | 2024-08-06 ClosureFast™ Micro Puncture Kit 5Fr/Ch (1.7mm) |
| 20886333227574 - ClosureFast Tumescent Infiltration Kit | 2024-08-06 ClosureFast™ Tumescent Infiltration Kit |
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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