EndoGrip 1177-01

GUDID 10816734021528

EndoGrip Grasping Forceps

DIVERSATEK HEALTHCARE, INC.

Flexible endoscopic tissue manipulation forceps, single-use Flexible endoscopic tissue manipulation forceps, single-use Flexible endoscopic tissue manipulation forceps, single-use

• 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

Customer Support Contacts

• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com

Device Dimensions

• 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

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00816734021521 [Primary]
GS1	10816734021528 [Package]; Contains: 00816734021521; Package: case [5 Units]; In Commercial Distribution

FDA Product Code

• GDJ: Clamp, Surgical, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-21
• Device Publish Date: 2018-08-01

Devices Manufactured by DIVERSATEK HEALTHCARE, INC.

• M78312011061 - Diversatek Healthcare: 2024-02-08 Basic Endoscopy Procedure Kit
• 10816734023355 - BullDog®: 2023-09-04 Air/Water Channel Cleaning Adapter for Fujifilm® GI Endoscope
• 00816734023181 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 15 FR
• 00816734023198 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 18 FR
• 00816734023204 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 21 FR
• 00816734023211 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 24 FR
• 00816734023228 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 27 FR
• 00816734023235 - SafeGuide® Single: 2023-08-22 Disposable Over the Guidewire Esophageal Dilator, 30 FR