| Primary Device ID | 08904428747603 |
| NIH Device Record Key | 188285df-728b-43be-855a-e3c1101e07c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type |
| Version Model Number | EI2215 |
| Company DUNS | 930270428 |
| Company Name | EON MEDITECH PRIVATE LIMITED |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 4 Millimeter |
| Angle | 40 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 40 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 40 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 40 degree |
| Outer Diameter | 4 Millimeter |
| Angle | 40 degree |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08904428723478 [Primary] |
| GS1 | 08904428747603 [Package] Contains: 08904428723478 Package: Laminated Box [1 Units] In Commercial Distribution |
| EQJ | Bur, Ear, Nose And Throat |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-18 |
| Device Publish Date | 2024-07-10 |
| 08904428747672 - OSSEOUS Blade - Inferior turbinate - N Type | 2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system |
| 08904428747665 - OSSEOUS Blade - Inferior turbinate - N Type | 2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system |
| 08904428747658 - OSSEOUS Blade-Straight Sinus Blades - N Type | 2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system |
| 08904428747641 - OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type | 2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system |
| 08904428747634 - OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type | 2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system |
| 08904428747627 - OSSEOUS Blade-Curved Sinus Blades - Type | 2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system |
| 08904428747610 - OSSEOUS Blade-Curved Sinus Blades - N Type | 2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system |
| 08904428747603 - OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type | 2024-07-18ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system to remove tissue, bone, or other obstructions in the sinuses. |
| 08904428747603 - OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type | 2024-07-18 ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system |