| Primary Device ID | 00850458007058 |
| NIH Device Record Key | 5216aaeb-d5bd-4d34-8f03-8065fe184b9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ShippertTech |
| Version Model Number | IO Needle Safety Sheath |
| Catalog Number | 5-IOSS-US |
| Company DUNS | 791379030 |
| Company Name | ACTUATED MEDICAL, 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850458007058 [Primary] |
| GS1 | 10850458007055 [Package] Package: [5 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-03 |
| Device Publish Date | 2023-07-26 |
| 00850458007041 - GripTract-GI Endoscopic Tissue Manipulator | 2025-04-10 GripTract Model 101 is a single use, non-sterile, endoscope accessory intended to assist in positioning the distal end of an end |
| 00850458007058 - ShippertTech | 2023-08-03The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, anti-needlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is indicated for use with 25mm and 45mm EZ-IO® Vascular Access Needles and BD Luer-Lok™ 10 mL Syringe. |
| 00850458007058 - ShippertTech | 2023-08-03 The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, anti-needlestick accessory to assist in the removal of intraoss |
| 00850458007003 - TubeClear | 2021-01-11 TubeClear Clearing Stem for clearing clogs / occlusions in silicone AMT, MIC, and MIC-KEY gastro-jejunostomy tubes size 14-22 Fr |
| 20850458007083 - TubeClear | 2018-10-25 TubeClear |
| 00850458007010 - TubeClear | 2018-07-06 |
| 20850458007090 - TubeClear | 2018-07-06 Clearing Stem |
| 20850458007106 - TubeClear | 2018-07-06 Clearing Stem |
| 20850458007113 - TubeClear | 2018-07-06 Clearing Stem |