| Primary Device ID | 07649988629310 |
| NIH Device Record Key | cfe3ddde-691a-4303-bcb2-51d9b48c1fda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OdneClean |
| Version Model Number | A-0006 |
| Catalog Number | A-0006 |
| Company DUNS | 775295061 |
| Company Name | Minitube AB |
| Device Count | 100 |
| DM Exempt | false |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07649988629310 [Primary] |
| GS1 | 07649988629327 [Unit of Use] |
| PEM | Dental Barriers And Sleeves |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-10 |
| Device Publish Date | 2024-06-01 |
| 07350069421562 - C20 Intraoral Protective Sheaths | 2025-04-09 Intraoral Protective Sheaths |
| 07350069420572 - C20 Intraoral Protective Sheaths | 2025-04-09 C20 Intraoral Protective Sheaths |
| 07649988629310 - OdneClean | 2024-06-10OdneClean barrier sleeves, 100pcs per box. |
| 07649988629310 - OdneClean | 2024-06-10 OdneClean barrier sleeves, 100pcs per box. |
| 07350069422835 - VALO™ Barrier Sleeves | 2024-05-09 Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchant |
| 07350069422842 - VALO™ Barrier Sleeves | 2024-05-09 Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchant |
| 07350069422859 - VALO™ Barrier Sleeves | 2024-05-09 Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchant |
| 07350069420763 - MIXPAC Protective Sleeve | 2022-10-11 MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protect the |
| 07350069420770 - MIXPAC Protective Sleeve | 2022-10-11 MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protect the |