| Primary Device ID | D248B20000 |
| NIH Device Record Key | 90c33b7f-501a-47e2-b622-9f279fc5bb4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIO-GUARD BULK REFILL-MAINTENANCE PACK(128 POUCHES) |
| Version Model Number | B2003 |
| Company DUNS | 009277971 |
| Company Name | HAGER WORLDWIDE, INC. |
| Device Count | 128 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D248B20000 [Unit of Use] |
| HIBCC | D248B20001 [Primary] |
| HIBCC | D248B20021 [Primary] |
| HIBCC | D248B20031 [Primary] |
| LRJ | Disinfectant, medical devices |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-24 |
| Device Publish Date | 2023-08-16 |
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| D2483552540 - BurButler ( 10 Hole Pink Base w/Lid) | 2024-07-23 Dental bur holder |
| D2483552560 - BurButler ( 10 Hole Blue Base w/Lid) | 2024-07-23 Dental bur holder |
| D2483552600 - BurButler ( 25 Hole Pink Base w/Lid) | 2024-07-23 Dental bur holder |