Primary Device ID | 10858303003030 |
NIH Device Record Key | 1c884668-60c9-4ce6-ab24-c217bde053bb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Syntervention |
Version Model Number | 5010B |
Company DUNS | 017535668 |
Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
Device Count | 2 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
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 | 00858303003033 [Primary] |
GS1 | 00858303003941 [Unit of Use] |
GS1 | 10858303003030 [Package] Contains: 00858303003033 Package: Case [100 Units] In Commercial Distribution |
FRL | Fiber, Medical, Absorbent |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-10-03 |
Device Publish Date | 2025-09-25 |
10850049994986 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent |
10850049994993 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent |
10858303003047 | SWASHER Ultra Low-Lint Surgical Towel. 4 Pack, Blue |
10858303003030 | SWASHER Ultra Low-Lint Surgical Towel. 2 Pack, Blue |
10858303003016 | SWIPER Medical Device Foam Wiper 2 Pack. |
10858303003009 | SWIPER Medical Device Foam Wiper 1 Pack |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SYNTERVENTION 85477538 4223265 Live/Registered |
Syntervention, Inc. 2011-11-21 |