Clinical HypoHolder

GUDID 00860010987940

Non-sterile pin base for use in clinical setting

TyTek Medical Inc.

Needle recapping device, reusable

• Primary Device ID: 00860010987940
• NIH Device Record Key: 42c5af35-9186-4f3d-88ca-2883ef825816
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clinical HypoHolder
• Version Model Number: 1004
• Company DUNS: 078589992
• Company Name: TyTek Medical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010987940 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-07-07
• Device Publish Date: 2025-06-27

Devices Manufactured by TyTek Medical Inc.

• 00860010987902 - Surgical HypoHolder: 2025-07-07 Magnetic pin and handle base
• 00860010987940 - Clinical HypoHolder: 2025-07-07Non-sterile pin base for use in clinical setting
• 00860010987940 - Clinical HypoHolder: 2025-07-07 Non-sterile pin base for use in clinical setting
• 00860010987926 - HypoPan: 2025-06-25 Autoclave pan and tray for Surgical HypoHolder
• 00860013471606 - HypoFoam: 2025-06-25 Single-use foam block for use with HypoHolder system
• 00855204008006 - TPAK: 2019-10-11 Tension Pneumothorax Decompression Needle: 14 gauge x 3.25"
• 00855204008013 - TVAC: 2019-10-11 Disposable portable suction unit
• 00855204008020 - Ptensys Bleeding Control Station: 2019-10-11 Ptensys Bleeding Control Station
• 00855204008037 - Ptensys Bleeding Control Kits: 2019-10-11 Ptensys Bleeding Control Kits