Allergy Tray

GUDID 00616784693637

DYNAREX CORPORATION

Hypodermic needle, single-use
Primary Device ID00616784693637
NIH Device Record Key34fbd204-5ec8-46dc-a6e8-00dfdafc9764
Commercial Distribution StatusIn Commercial Distribution
Brand NameAllergy Tray
Version Model Number6936
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784693606 [Unit of Use]
GS100616784693613 [Primary]
GS100616784693637 [Package]
Contains: 00616784693613
Package: Master Case [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2017-09-08

Devices Manufactured by DYNAREX CORPORATION

00840117341210 - Medicine Cups 1oz 2024-11-05
00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm 2024-11-01 Sterile-EO
00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm 2024-11-01 Sterile-EO
00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm 2024-11-01 Sterile-EO
00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm 2024-11-01 Sterile-Eo
00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm 2024-11-01 Sterile-Eo
00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm2024-11-01 Sterile-Eo
00840117313026 - Resp-O2 Endotracheal Tube Cuffed, 7.0 mm 2024-11-01 Sterile-Eo

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