| Primary Device ID | 10618125168160 |
| NIH Device Record Key | 70016850-1d83-4a99-9c83-31234e57c375 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zonare |
| Version Model Number | 29187 |
| Catalog Number | 29187 |
| Company DUNS | 063519193 |
| Company Name | TIDI PRODUCTS, LLC |
| Device Count | 1 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618125168163 [Primary] |
| GS1 | 01618125168162 [Previous] |
| GS1 | 10618125168160 [Package] Contains: 00618125168163 Package: Case [25 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-07 |
| Device Publish Date | 2022-09-29 |
| 10618125168160 | Zonare Clear Polyethylene Sterile 36in x 22in x 1in 25 per Case |
| 01618125168162 | Zonare Clear Polyethylene Sterile 36in x 22in x 1in 25 per Case |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ZONARE 78154372 3066505 Live/Registered |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. 2002-08-14 |