| Primary Device ID | 20811870035368 |
| NIH Device Record Key | e9a6abe3-88ed-420e-b2ed-408738fc70cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Custom Healthcare Systems, Inc. |
| Version Model Number | D21-9064 |
| Company DUNS | 175254820 |
| Company Name | CUSTOM HEALTHCARE SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | 00811870035364 [Primary] |
| GS1 | 20811870035368 [Package] Contains: 00811870035364 Package: NA [100 Units] In Commercial Distribution |
| FQM | Bandage, Elastic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
[20811870035368]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-08 |
| Device Publish Date | 2020-11-30 |
| 20811870036310 | R1554 |
| 20811870036341 | B9-16938A |
| 20811870036396 | KM3405353-2 |
| 20811870035931 | B9-19835 |
| 20811870035368 | D21-9064 |
| 20811870036235 | B9-15934C |