| Primary Device ID | 10850049994870 | 
| NIH Device Record Key | 51d83a56-ec31-4c0f-91fa-f3d7fe496823 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Syntervention | 
| Version Model Number | 4008-303 | 
| Company DUNS | 017535668 | 
| Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. | 
| Device Count | 2 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | MR Safe | 
| 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 | 00850049993111 [Unit of Use] | 
| GS1 | 00850049994873 [Primary] | 
| GS1 | 10850049994870 [Package] Contains: 00850049994873 Package: Case [300 Units] In Commercial Distribution | 
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-10-06 | 
| Device Publish Date | 2025-09-26 | 
| 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 | 
| 10850049994979 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994962 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994955 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994948 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994931 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994924 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994917 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994900 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994894 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994887 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994870 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| 10850049994863 | SWICKER is a sterile foam sponge designed for single-patient use. SWICKER is a highly absorbent | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SYNTERVENTION  85477538  4223265 Live/Registered | Syntervention, Inc. 2011-11-21 |