GRI

GUDID 16931918100067

Gentleheel Devices are made of lower housing, upper housing, spring, blade, spring holder, blade holder, safety lock, button, etc. Materials of all co

GRI Medical & Electronic Technology Co., Ltd.

Manual blood lancing device, single-use

• Primary Device ID: 16931918100067
• NIH Device Record Key: da9aa386-adad-4069-a377-d8a6034e5a48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRI
• Version Model Number: GHN10X50
• Company DUNS: 679894738
• Company Name: GRI Medical & Electronic 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16931918100067 [Primary]

FDA Product Code

• FMK: Lancet, Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-29

Devices Manufactured by GRI Medical & Electronic Technology Co., Ltd.

• 06931918122109 - Alleset: 2026-02-23 Clear bowl_500cc_Non-sterile_390ea/cs
• 26931918173501 - Invenio: 2026-02-23 Drape_GYN/Urology_285cmx337.5cm_Sterile_14ea/cs
• 26931918101047 - Alleset: 2026-02-17 Skin Marker_Standard Tip with Ruler and Lables_ XL Prep-Resistant Ink_Sterile_100ea/cs
• 26931918108411 - Alleset: 2026-02-17 Skin Marker_Fine Tip with Ruler and Labels_XL Prep-Resistant Ink_Sterile_100ea/cs
• 26931918139798 - Alleset: 2026-02-17 Allesorb Underpad_Select__24"x36"/61x91cm_non-sterile_10ea/bag_6bag/cs
• 26931918152353 - Alleset: 2026-02-17 Skin Marker_Dual Tip Skin Marker with Ruler and Labels_sterile_100ea/cs
• 26931918161324 - Alleset: 2026-02-17 Skin Marker_Standard Tip with Ruler and Labels_sterile_100ea/cs
• 26931918171170 - Alleset: 2026-02-17 Camera Drape_7inx96in_Sterile_25ea/cs