| Primary Device ID | B097IMD006XLO1 |
| NIH Device Record Key | c9c0842c-4060-4e44-a95c-397ccb824850 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Block |
| Version Model Number | Extra Large - Extra Long - Soft |
| Company DUNS | 080156251 |
| Company Name | INTERNATIONAL MEDICAL DEVICES, INC. |
| Device Count | 1 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B097IMD006XLO1 [Primary] |
| MIB | Elastomer, Silicone Block |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
[B097IMD006XLO1]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-15 |
| B097IMD006XXL1 | Extra Extra Large - Soft |
| B097IMD006XLO1 | Extra Large - Extra Long - Soft |
| B097IMD006XL1 | Extra Large - Soft |
| B097IMD006LLO1 | Large - Extra Long - Soft |
| B097IMD006L1 | Large - Soft |
| B097IMD001XXL1 | Extra Extra Large - Extra Soft |
| B097IMD001XL1 | Extra Large - Extra Soft |
| B097IMD001L1 | Large - Extra Soft |