| Primary Device ID | 08800049414231 |
| NIH Device Record Key | fa48a2ec-7710-4fb1-a031-e670b499bd46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIOnavi Guide |
| Version Model Number | GUIDE 02 A02(a,b) |
| Company DUNS | 631085206 |
| Company Name | DIO Corporation |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800049414231 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
[08800049414231]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-26 |
| Device Publish Date | 2025-09-18 |
| 08800049414293 | GUIDE 02 A05(a,b) |
| 08800049414279 | GUIDE 02 A04(a,b) |
| 08800049414255 | GUIDE 02 A03(a,b) |
| 08800049414231 | GUIDE 02 A02(a,b) |
| 08800049414217 | GUIDE 02 A01(a,b) |