| Primary Device ID | 03760349800514 |
| NIH Device Record Key | 6af5b24d-be09-4170-aeed-e7747c1f3d30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EFFITEC NEEDLE 27G SHORT |
| Version Model Number | C3029 |
| Catalog Number | C3029 |
| Company DUNS | 640616736 |
| Company Name | DENTALHITEC |
| 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 | false |
| 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 |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760349800514 [Primary] |
| DZM | Needle, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-30 |
| Device Publish Date | 2023-08-22 |
| 03760349801054 - QUICKSLEEPER 5C_A2 US/CA | 2025-12-30 1 QuickSleeper 5 handpiece and control box 1 wireless pedal 1 power cable 1 power supply, 6 containers 1 user manual 1 box of de |
| 03760349800507 - EFFITEC NEEDLE 30G EXTRA SHORT | 2023-08-30 1 box of 100 single use needles 30G 9mm |
| 03760349800514 - EFFITEC NEEDLE 27G SHORT | 2023-08-301 box of 100 single use needles 27G 16mm |
| 03760349800514 - EFFITEC NEEDLE 27G SHORT | 2023-08-30 1 box of 100 single use needles 27G 16mm |
| 03760349800521 - EFFITEC NEEDLE 30G SHORT | 2023-08-30 1 box of 100 single use needles 30G 16mm |
| 03760349809913 - SleeperOne 5 | 2023-08-30 1 SleeperOne 5 handpiece and control box 1 wireless pedal 1 battery charger 1 power supply, 10 containers 1 user manual 2 boxes |
| 03760349809951 - Soan | 2023-08-30 1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 boxes of dental needles C3022 |