| Primary Device ID | D766431650 |
| NIH Device Record Key | 60103809-bc9e-4ada-b72e-738d12405328 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUALITOUCH LATEX PF L/R FIT EXAM NATURAL 6.5 |
| Version Model Number | 43165 |
| Catalog Number | 43165 |
| Company DUNS | 061081477 |
| Company Name | Smarthealth, Inc. |
| Device Count | 50 |
| DM Exempt | true |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com | |
| Phone | 1-800-522-0800 |
| info@smartpractice.com |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D766431650 [Unit of Use] |
| HIBCC | D766431651 [Primary] |
| HIBCC | D766431652 [Package] Contains: D766431651 Package: case [10 Units] In Commercial Distribution |
| LYY | Latex Patient Examination Glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-26 |
| Device Publish Date | 2023-07-18 |
| 00854498007047 - SmartPractice | 2025-02-25 Finn Chamber FLAT PATCH-BOX, 50X10 |
| D7664311062 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XS | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XS*200 |
| D7664311072 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM SM*200 |
| D7664311082 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM MED*200 |
| D7664311092 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM LG*200 |
| D7664311102 - REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL | 2023-08-15 GLV REFLECTION SAPPHIRE SENSITIVE NITRILE PF EXAM XL*200 |
| D766408712 - QUALITOUCH LATEX PF EXAM NATURAL CF XS* | 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF XS*100 |
| D766408722 - QUALITOUCH LATEX PF EXAM NATURAL CF SM | 2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF SM*100 |