| Primary Device ID | 10816734021528 |
| NIH Device Record Key | 0f2b42f1-70ca-4653-9d24-ffc50e209a94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoGrip |
| Version Model Number | 1177-01 |
| Catalog Number | 1177-01 |
| Company DUNS | 030650113 |
| Company Name | DIVERSATEK HEALTHCARE, INC. |
| 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 | false |
| 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 |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com |
| Width | 8.3 Millimeter |
| Width | 8.3 Millimeter |
| Width | 8.3 Millimeter |
| Width | 8.3 Millimeter |
| Width | 8.3 Millimeter |
| Width | 8.3 Millimeter |
| Width | 8.3 Millimeter |
| Width | 8.3 Millimeter |
| Width | 8.3 Millimeter |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816734021521 [Primary] |
| GS1 | 10816734021528 [Package] Contains: 00816734021521 Package: case [5 Units] In Commercial Distribution |
| GDJ | Clamp, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-21 |
| Device Publish Date | 2018-08-01 |
| 10816734023515 - BullDog® | 2025-12-15 Disposable Bronchoscope Valves Set |
| 00816734022825 - Zvu® | 2025-11-24 ZVU® Functional GI Software |
| M78312011161 - Diversatek Healthcare | 2025-11-24 Basic Endoscopy Procedure Kit |
| 00816734023433 - Diversatek Healthcare | 2025-05-26 Manometry Starter Kit |
| 00816734023440 - Diversatek Healthcare | 2025-05-26 HRiM2 High Resolution Impedance Manometry Probe Kit |
| 00816734023457 - Diversatek Healthcare | 2025-05-26 HRiM SD High Resolution Impedance Manometry Probe Kit |
| 00816734023464 - Diversatek Healthcare | 2025-05-26 High Resolution Anorectal Manometry Probe Kit |
| 00816734023471 - Diversatek Healthcare | 2025-05-26 Anal Sphincter Electromyography Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOGRIP 74388146 1817852 Dead/Cancelled |
Biomedix, Inc. 1993-05-10 |