Clinical HypoHolder - Non-sterile pin base for use in clinical setting
2025-06-27
TYTEK MEDICAL INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004551550 | 3004551550 | TYTEK MEDICAL INC | 1 | N | 2026-01-01 | 8904 Beckett Rd. West Chester OH US 45069 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 127393 | 2049970196 | K133528 | H&H EMERGENCY CRICOTHYROTOMY KIT | JOH | 2014-07-03 |
| 127393 | 1384243425 | ||||
| 127393 | 1506186099 | ||||
| 127393 | 1790312248 | ||||
| 127393 | 1840096805 | ||||
| 127393 | 1886708967 | ||||
| 127393 | 1923446476 | ||||
| 127393 | 1045671946 | ||||
| 127393 | 1147114268 | ||||
| 127393 | 1641525744 | ||||
| 127393 | 1696027560 | ||||
| 127393 | 1823459363 | ||||
| 127393 | 1922263921 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JOH | 2 | 2014-07-03 |
GUDID#
Surgical HypoHolder - Magnetic pin and handle base
2025-06-27
HypoFoam - Single-use foam block for use with HypoHolder system
2025-06-17
HypoPan - Autoclave pan and tray for Surgical HypoHolder
2025-06-17
PneumoDart - Superior Tension Pneumothorax Decompression Needle
2019-10-03
EZ GAUZE - EZ Gauze - gauze /sponge, nonresorbable for external use
2019-10-03
TYTEK TRAUMA BANDAGE - Abdominal Trauma Bandage
2019-10-03
TYTEK TRAUMA BANDAGE - "6"" Trauma Bandage"
2019-10-03
TYTEK TRAUMA BANDAGE - "4"" Trauma Bandage"
2019-10-03
TPAK - "Tension Pneumothorax Decompression Needle: 10 gauge x 3.25"""
2019-10-03
Ptensys Bleeding Control Kits - TM-401
2019-10-03
Ptensys Bleeding Control Station - TM-400
2019-10-03
TVAC - Disposable portable suction unit
2019-10-03
TPAK - "Tension Pneumothorax Decompression Needle: 14 gauge x 3.25"""
2019-10-03