| Primary Device ID | 00840113231546 |
| NIH Device Record Key | 119d8ee8-786b-4893-a391-a24d8f96fcd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlastiBell Circumcision Device |
| Version Model Number | 9211 |
| Company DUNS | 027680821 |
| Company Name | ASPEN SURGICAL PRODUCTS, 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840113231546 [Primary] |
| FHG | Bell, circumcision |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-07 |
| Device Publish Date | 2023-02-27 |
| 00840113231676 | 1.7 cm PlastiBell Circumcision Device |
| 00840113231669 | 1.5 cm PlastiBell Circumcision Device |
| 00840113231652 | 1.4 cm PlastiBell Circumcision Device |
| 00840113231645 | 1.3 cm PlastiBell Circumcision Device |
| 00840113231638 | 1.2 cm PlastiBell Circumcision Device |
| 00840113231621 | 1.1 cm PlastiBell Circumcision Device |
| 00840113231614 | PlastiBell Circumcision Device, Physician Bulk Pack |
| 00840113231607 | 1.7 cm PlastiBell Circumcision Device |
| 00840113231591 | 1.5 cm PlastiBell Circumcision Device |
| 00840113231584 | 1.4 cm PlastiBell Circumcision Device |
| 00840113231577 | 1.3 cm PlastiBell Circumcision Device |
| 00840113231560 | 1.2 cm PlastiBell Circumcision Device |
| 00840113231546 | 1.1 cm PlastiBell Circumcision Device |
| 00840113231539 | PlastiBell Circumcision Device, Hospital Bulk Pack |