ZYNRELEF 10 mL Vial Access Needle (VAN) 12027-325-31

GUDID 00347426505079

ZYNRELEF 10 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit

Heron Therapeutics, Inc.

Vial/bottle adaptor, non-hermetic
Primary Device ID00347426505079
NIH Device Record Keyafe060ad-231d-4cef-9d30-7116547941c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameZYNRELEF 10 mL Vial Access Needle (VAN)
Version Model NumberN/A
Catalog Number12027-325-31
Company DUNS102099843
Company NameHeron Therapeutics, Inc.
Device Count1
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
GS100347426505079 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-10
Device Publish Date2024-10-02

Devices Manufactured by Heron Therapeutics, Inc.

00347426505086 - ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement2024-11-15 ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement
00347426506083 - ZYNRELEF 20 mL Vial Access Needle (VAN) Replacement2024-11-15 ZYNRELEF 20 mL Vial Access Needle (VAN) Replacement
00347426505079 - ZYNRELEF 10 mL Vial Access Needle (VAN)2024-10-10ZYNRELEF 10 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit
00347426505079 - ZYNRELEF 10 mL Vial Access Needle (VAN)2024-10-10 ZYNRELEF 10 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit
00347426506076 - ZYNRELEF 20 mL Vial Access Needle (VAN)2024-10-10 ZYNRELEF 20 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit
00347426902106 - ZYNRELEF Luer Lock Applicator2021-07-23
00347426903059 - ZYNRELEF Replacement Vented Vial Spikes2021-07-23 Base package contains quantity of 5 vented vial spikes.
00347426904087 - ZYNRELEF Replacement 12 mL Luer Lock Syringes2021-07-23 Base package contains quantity of 8 of the 12 mL Luer Lock Syringes.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.