Primary Device ID | 00347426902106 |
NIH Device Record Key | a7165faf-8e1d-487d-858c-52d262d7e619 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ZYNRELEF Luer Lock Applicator |
Version Model Number | N/A |
Catalog Number | 709689 |
Company DUNS | 102099843 |
Company Name | Heron Therapeutics, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00347426901017 [Primary] |
GS1 | 00347426902106 [Package] Contains: 00347426901017 Package: [10 Units] In Commercial Distribution |
FMF | Syringe, Piston |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-07-23 |
Device Publish Date | 2021-07-15 |
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 Applicator | 2021-07-23 |
00347426902106 - ZYNRELEF Luer Lock Applicator | 2021-07-23 |
00347426903059 - ZYNRELEF Replacement Vented Vial Spikes | 2021-07-23 Base package contains quantity of 5 vented vial spikes. |
00347426904087 - ZYNRELEF Replacement 12 mL Luer Lock Syringes | 2021-07-23 Base package contains quantity of 8 of the 12 mL Luer Lock Syringes. |