Primary Device ID | 10886333222282 |
NIH Device Record Key | 4b741572-b89e-4d8a-987d-49d08932e3e2 |
Commercial Distribution Discontinuation | 2017-06-27 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | One Step Micro Introducer System |
Version Model Number | 497821 |
Catalog Number | 497821 |
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 Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00886333222285 [Primary] |
GS1 | 10886333222282 [Package] Contains: 00886333222285 Package: Box [10 Units] Discontinued: 2017-06-27 Not in Commercial Distribution |
GS1 | 20886333222289 [Package] Contains: 00886333222285 Package: Box [50 Units] Discontinued: 2017-06-27 Not 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 | 2016-09-09 |
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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 |