GRIT™

GUDID 06971890564597

Jiangsu Grit Medical Technology Co., Ltd.

Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use

• Primary Device ID: 06971890564597
• NIH Device Record Key: af68185c-097a-4b80-bee0-32312b53a058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRIT™
• Version Model Number: GM-BD-A1-11-850
• Company DUNS: 554536935
• Company Name: Jiangsu Grit Medical Technology Co., Ltd.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971890564597 [Primary]
GS1	16971890564594 [Package]; Package: Inner Box [3 Units]; In Commercial Distribution
GS1	26971890564591 [Package]; Package: Outer Box [54 Units]; In Commercial Distribution

FDA Product Code

• KNQ: Dilator, Esophageal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-21
• Device Publish Date: 2021-04-13

On-Brand Devices [GRIT™]

• 06971890564610: GM-BD-A1-13-850
• 06971890564603: GM-BD-A1-12-850
• 06971890564580: GM-BD-A1-10-850
• 06971890564573: GM-BD-A1-09-850
• 06971890564597: GM-BD-A1-11-850
• 06971890564566: GM-BD-A1-08-850
• 06971890564627: GM-BD-A1-14-850
• 06971890564689: GM-BD-A1-20-850
• 06971890564672: GM-BD-A1-19-850
• 06971890564665: GM-BD-A1-18-850
• 06971890564658: GM-BD-A1-17-850
• 06971890564641: GM-BD-A1-16-850
• 06971890564634: GM-BD-A1-15-850