Primary Device ID | 20886333214000 |
NIH Device Record Key | ba60ace4-d016-47a0-9f1e-cdcbce746488 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Catheter Introducer Pack |
Version Model Number | 496360E |
Catalog Number | 496360E |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00886333214006 [Primary] |
GS1 | 20886333214000 [Package] Contains: 00886333214006 Package: Box [10 Units] In Commercial Distribution |
DRE | Dilator, Vessel, For Percutaneous Catheterization |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-06-07 |
Device Publish Date | 2016-09-21 |
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 |
20886333227444 - ClosureFast Arterial Needle | 2024-07-29 ClosureFast™ Arterial Needle Ultra Thin Wall with Echogenic Tip 19G (1.067mm) x 2.75" (70mm) Ultra Thin Wall with Echogenic Ti |