| Primary Device ID | 20811870035016 |
| NIH Device Record Key | 58698e59-7f59-4bd3-8e98-c415e28c295b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Custom Healthcare Systems Inc. |
| Version Model Number | D8-9425B |
| Company DUNS | 175254820 |
| Company Name | CUSTOM HEALTHCARE SYSTEMS, 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811870035012 [Primary] |
| GS1 | 20811870035016 [Package] Contains: 00811870035012 Package: N/A [24 Units] In Commercial Distribution |
| KDD | Kit, Surgical Instrument, Disposable |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
[20811870035016]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-29 |
| Device Publish Date | 2018-07-29 |