| Primary Device ID | 10889950110475 |
| NIH Device Record Key | bc0ee16f-9cd6-4e6b-9df3-ab4b8260821e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | IMS-2220 |
| Catalog Number | IMS-2220 |
| Company DUNS | 005085972 |
| Company Name | HU-FRIEDY MFG. CO., LLC |
| Device Count | 480 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 18004837433 |
| info@hu-friedy.com | |
| Phone | 18004837433 |
| info@hu-friedy.com |
| Area/Surface Area | 400 Square inch |
| Area/Surface Area | 400 Square inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889950110475 [Primary] |
| GS1 | 10889950111403 [Unit of Use] |
| FRG | Wrap, Sterilization |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2019-01-14 |
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| 10889950133610 - Hu-Friedy | 2025-12-29 HFG Hygienist Scaler, EE2.0 Harmony |
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| 10889950133795 - Hu-Friedy | 2025-12-29 Pattison Gracey Lite 7/8, EE2.0 Harmony |
| 10889950133801 - Hu-Friedy | 2025-12-29 Pattison Gracey Lite 11/12, EE2.0 Harmony |
| 10889950133818 - Hu-Friedy | 2025-12-29 Pattison Gracey Lite 13/14, EE2.0 Harmony |
| 10889950133825 - Hu-Friedy | 2025-12-29 Pattison Gracey Lite 11/14, EE2.0 Harmony |