| Primary Device ID | M9853510000 |
| NIH Device Record Key | c65f300d-6678-49e9-9904-24977aebd15f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spore Strips Steam & Chemiclave |
| Version Model Number | 10e5 |
| Catalog Number | 3-5-1000 |
| Company DUNS | 102530326 |
| Company Name | MESA LABORATORIES, INC. |
| Device Count | 1000 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M9853510000 [Unit of Use] |
| HIBCC | M9853510001 [Primary] |
| FRC | Indicator, Biological 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 | 2023-07-18 |
| Device Publish Date | 2023-07-10 |
| M985EXPOSSC5100 - ExpoSure Steam | 2023-11-30 Self contained biological indicator, 10e5 population, 100 count box |
| M985EXPOSSC525 - ExpoSure Steam | 2023-11-30 Self contained biological indicator, 10e5 population, 25 count box |
| M985EXPOSSC6100 - ExpoSure Steam | 2023-11-30 Self contained biological indicator, 10e6 population, 100 count in box |
| M9851610001 - Spore Strip - EO/Dry Heat | 2023-07-18 Bacillus atrophaeus log 6 strips in 1000ct bag private label for GKE |
| M9853510000 - Spore Strips Steam & Chemiclave | 2023-07-18Geobacillus Stearothermophilus log 5 strip in 1000ct bag private label for GKE |
| M9853510000 - Spore Strips Steam & Chemiclave | 2023-07-18 Geobacillus Stearothermophilus log 5 strip in 1000ct bag private label for GKE |
| M9853610000 - Spore Strip -Steam & Chemiclave | 2023-07-18 Geobacillus strearothermophilus log 6 strip in 1000ct bag private label for GKE |
| M985CIBDTLF0 - Bowie Dick Type Test | 2021-02-19 ProChem B-D Bowie Dick Type Test pack |
| M985CIDHI2 - Mesa Labs Dry Heat Indicator Labels | 2021-02-19 Dry Heat Indicator Labels - 1000 labels per roll, 10 rolls per pack |