| Primary Device ID | 10886333215338 |
| NIH Device Record Key | f11df4ea-0a4f-4255-8e28-18126f78afee |
| Commercial Distribution Discontinuation | 2017-08-07 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | One Step Custom Kit Micro-Introducer |
| Version Model Number | 497864 |
| Catalog Number | 497864 |
| 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 | 00886333215331 [Primary] |
| GS1 | 10886333215338 [Package] Contains: 00886333215331 Package: Box [10 Units] Discontinued: 2017-08-07 Not in Commercial Distribution |
| GS1 | 20886333215335 [Package] Contains: 00886333215331 Package: Box [50 Units] Discontinued: 2017-08-07 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 | 2016-09-20 |
| 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 |