ZYNRELEF Luer Lock Applicator 709689

GUDID 00347426902106

Heron Therapeutics, Inc.

Collection syringe adaptor, single-use
Primary Device ID00347426902106
NIH Device Record Keya7165faf-8e1d-487d-858c-52d262d7e619
Commercial Distribution StatusIn Commercial Distribution
Brand NameZYNRELEF Luer Lock Applicator
Version Model NumberN/A
Catalog Number709689
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100347426901017 [Primary]
GS100347426902106 [Package]
Contains: 00347426901017
Package: [10 Units]
In Commercial Distribution

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-23
Device Publish Date2021-07-15

Devices Manufactured by Heron Therapeutics, Inc.

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
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.

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