| Primary Device ID | 00860000763615 |
| NIH Device Record Key | 63c15018-dbac-4ccb-aa3a-7288f2863e12 |
| Commercial Distribution Discontinuation | 2021-11-26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IND400S |
| Version Model Number | IND400S |
| Catalog Number | IND400S |
| Company DUNS | 187129721 |
| Company Name | INDILAB INC. |
| Device Count | 250 |
| 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 | false |
| OTC Over-The-Counter | false |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Length | 4 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000763608 [Unit of Use] |
| GS1 | 00860000763615 [Primary] |
| JOJ | Indicator, Physical/Chemical Sterilization Process |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-28 |
| Device Publish Date | 2018-11-27 |