Hygoformic Bio UB100

GUDID 07393507113131

Saliva ejector

J.H. Orsing AB

Dental suction system cannula, single-use

• Primary Device ID: 07393507113131
• NIH Device Record Key: 204cbc49-3d01-4353-b837-c1256bc46955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hygoformic Bio
• Version Model Number: Hygoformic
• Catalog Number: UB100
• Company DUNS: 354287922
• Company Name: J.H. Orsing AB
• Device Count: 100
• 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: false
• 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	07393507111076 [Unit of Use]
GS1	07393507112073 [Primary]
GS1	07393507113131 [Package]; Contains: 07393507112073; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• DYN: Mouthpiece, Saliva Ejector

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [Hygoformic Bio]

• 07393507111076: Saliva ejector
• 07393507113131: Saliva ejector