| Primary Device ID | 08800053011389 |
| NIH Device Record Key | 30fe3f0a-fb6e-4154-a4b0-082f7a5713ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SQ Guide Sleeve |
| Version Model Number | DSQGS45C |
| Company DUNS | 694721181 |
| Company Name | DENTIS CO. ,LTD |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800053011389 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
[08800053011389]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-08 |
| Device Publish Date | 2021-05-31 |
| 08800053011389 | Dental Implant Instrument / SQ Guide Sleeve |
| 08800053011402 | Dental Implant Instrument / SQ Guide Sleeve |
| 08800053011396 | Dental Implant Instrument / SQ Guide Sleeve |