| Primary Device ID | 04053755201587 |
| NIH Device Record Key | da9cd1b7-51d1-4c01-a6de-e440dcf958a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEINE diSTANCE |
| Version Model Number | 000 |
| Catalog Number | K-000.34.103 |
| Company DUNS | 315274563 |
| Company Name | Heine Optotechnik GmbH & Co. KG |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com | |
| Phone | +1 (603) 742-7103 |
| service@heine-na.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04053755201587 [Primary] |
| KYT | Light, Examination, Medical, Battery Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-14 |
| Device Publish Date | 2024-02-06 |
| 04053755191673 - BETA 200 LED RETINOSCOPE | 2024-07-17 3,5 V |
| 04053755186556 - BETA 200 LED VET. OTOSCOPE | 2024-07-05 |
| 04053755202133 - K180 LED F.O. OTOSCOPE | 2024-07-05 |
| 04053755202232 - K 180 LED OPHTHALMOSCOPE | 2024-07-05 |
| 04053755114658 - BETA 200 OTOSCOPE | 2024-06-28 since 2024-05 in LED version: BETA 200 LED F.O. OTOSCOPE |
| 04053755114696 - K 180 OTOSCOPE | 2024-06-28 since 2024-05 in LED version: K180 LED OTOSCOPE |
| 04053755119981 - BETA 200 OPHTHALMOSCOPE | 2024-06-28 since 2024-05 in LED version: BETA 200 LED OPHTHALMOSCOPE |
| 04053755120000 - BETA 200 S OPHTHALMOSCOPE | 2024-06-28 since 2024-05 in LED version: BETA 200S LED OPHTHALMOSCOPE 2.5V |