HypoPan

GUDID 00860010987926

Autoclave pan and tray for Surgical HypoHolder

TyTek Medical Inc.

Instrument tray, reusable
Primary Device ID00860010987926
NIH Device Record Key4602fea4-d448-4f9a-b279-bf806c62c506
Commercial Distribution StatusIn Commercial Distribution
Brand NameHypoPan
Version Model Number1009
Company DUNS078589992
Company NameTyTek Medical Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010987926 [Primary]

FDA Product Code

LRPTray, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


[00860010987926]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-25
Device Publish Date2025-06-17

Devices Manufactured by TyTek Medical Inc.

00860010987926 - HypoPan2025-06-25Autoclave pan and tray for Surgical HypoHolder
00860010987926 - HypoPan2025-06-25 Autoclave pan and tray for Surgical HypoHolder
00860013471606 - HypoFoam2025-06-25 Single-use foam block for use with HypoHolder system
00855204008006 - TPAK2019-10-11 Tension Pneumothorax Decompression Needle: 14 gauge x 3.25"
00855204008013 - TVAC2019-10-11 Disposable portable suction unit
00855204008020 - Ptensys Bleeding Control Station2019-10-11 Ptensys Bleeding Control Station
00855204008037 - Ptensys Bleeding Control Kits2019-10-11 Ptensys Bleeding Control Kits
00855204008051 - TPAK2019-10-11 Tension Pneumothorax Decompression Needle: 10 gauge x 3.25"
00855204008068 - TYTEK TRAUMA BANDAGE2019-10-11 4" Trauma Bandage

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