| Primary Device ID | 00653159007057 |
| NIH Device Record Key | 861805a7-8616-42ad-bc34-507a8c6450d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Case Medical, Inc |
| Version Model Number | SCS01SH |
| Catalog Number | SCS01SH |
| Company DUNS | 053057972 |
| Company Name | CASE MEDICAL INC. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653159007057 [Primary] |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-06 |
| Device Publish Date | 2022-03-29 |
| 00653159010156 | MULTI-ENZYMATIC SURFACE CLEANER WIPES |
| 00653159007057 | SEAL TAMPER EVIDENT REPAIR (1000/PK) |
| 00653159005558 | REPAIR SEAL (1000/PK) |
| 00653159004551 | BSKL04 LONG SIZE BASKET 25.3x9.6x4 in. |
| 00653159004544 | BSKL03 LONG SIZE BASKET 25.3x9.6x3 in. |
| 00653159003691 | BIOHAZARD SEAL (1000/PK) |
| 00653159000904 | BSKQ03 MID SIZE BASKET (15.8"X9.7"x3.2") |
| 00653159000690 | BSKF04 FULL SIZE BASKET 21.3x9.6x4 in. |
| 00653159000683 | BSKF03 FULL SIZE BASKET(21.3"x9.7"x3.2" |
| 00653159000485 | BRACKET SMALL BUMPER 1.7x0.4 in. (10/PK) |
| 00653159004513 | BRACKET 12MM DIA. 1.5x1.0 in., (10/PK) |
| 00653159004483 | BRACKET 5MM DIA. 1.1x1.0 in., (10/PK) |
| 00653159004438 | BRACKET 1-3MM DIA. 1.1x1.0 in. (10/PK) |
| 00653159004421 | BRACKET SMALL BUMPER 1.7x0.4 in. (10/PK) |
| 00653159004346 | BRACKET 5-10MM DIA. 1.1x1.0 in., (10/PK) |
| 00653159004322 | BRACKET, 2-4MM DIA. 1.1x1 in., (10/pk) |
| 00653159004315 | BRACKET 28MM DIA. 2.2x1.6 in., (10/PK) |
| 00653159004308 | BRACKET 22MM DIA. 1.9x1.4 in., (10/PK) |
| 00653159004292 | BRACKET 18MM DIA. 1.8x1.4 in., (10/PK) |