Hemo-wedge

GUDID E29950229

13 mm (M)

Polydentia SA

Dental wedge, single-use

• Primary Device ID: E29950229
• NIH Device Record Key: 35276f87-f746-45f1-81a8-2a01ba1c3ac8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemo-wedge
• Version Model Number: 5022
• Company DUNS: 481461598
• Company Name: Polydentia SA
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch
• Phone: +41919462948
• Email: info@polydentia.ch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E29950220 [Primary]
HIBCC	E29950229 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790555

FDA Product Code

• DZN: Instruments, Dental Hand

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: 2022-07-11
• Device Publish Date: 2022-07-01

On-Brand Devices [Hemo-wedge]

• E29950250: assorted
• E29950249: 17 mm (XL)
• E29950239: 15 mm (L)
• E29950229: 13 mm (M)
• E29950219: 12 mm (S)
• E29950209: 11 mm (XS)