| Primary Device ID | M991TH011002 |
| NIH Device Record Key | 9140a723-0d22-4c94-af6a-d63e81d5e8de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tidal High-Flow Non-coring Needle |
| Version Model Number | Tidal-HF |
| Catalog Number | TH01100 |
| Company DUNS | 013861471 |
| Company Name | NORFOLK MEDICAL |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(847)674-7075 |
| npheil@norfolkmedical.com |
| Needle Gauge | 18 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M991TH011001 [Primary] |
| HIBCC | M991TH011002 [Package] Contains: M991TH011001 Package: Box [10 Units] In Commercial Distribution |
| FMI | Needle, hypodermic, single lumen |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M991TH011002]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2015-10-06 |
| M991TH023002 | 16G x 1-1/4" Tidal High-Flow Non-coring Needle |
| M991TH022002 | 16G x 1" Tidal High-Flow Non-coring Needle |
| M991TH021002 | 16G x 3/4" Tidal High-Flow Non-coring Needle |
| M991TH013002 | 18G x 1-1/4" Tidal High-Flow Non-coring Needle |
| M991TH012002 | 18G x 1" Tidal High-Flow Non-coring Needle |
| M991TH011002 | 18G x 3/4" Tidal High-Flow Non-coring Needle |