| 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 |
| D248137720 - Almore Aluminum Oxide | 2024-05-28 Aluminum Oxide 1 lb. |
| D248137730 - Almore Aluminum Oxide | 2024-05-28 Aluminum Oxide 4lb. |
| D248B1619B0 - Duration | 2024-05-28 Air/Water Syringe Tips ( Stainless Steel) |
| D248B16280 - Uni-Tip | 2024-05-28 Air/Water Syringe Tips |
| D2481550180 - Reso-Pac Hydrophilic Periodontal Dressing | 2024-05-27 |
| D2481550190 - Reso-Pac Hydrophilic Periodontal Dressing | 2024-05-27 |
| D2483553190 - Plast Frame | 2024-04-24 Rubber dam frame |
| D248222300 - SafeDispense - Silver | 2024-04-22 Floss Holder/dispenser |