Lip Retractor LR-00-01

GUDID 07333117000162

Gestenco International AB

Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor

• Primary Device ID: 07333117000162
• NIH Device Record Key: 5d0242a8-9f0e-4e90-83be-8d3048db74cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lip Retractor
• Version Model Number: LR-00-01
• Catalog Number: LR-00-01
• Company DUNS: 354936098
• Company Name: Gestenco International AB
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	07333117000162 [Primary]

FDA Product Code

• EIF: Accessories, Retractor, Dental

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: 2020-10-23
• Device Publish Date: 2020-10-15

On-Brand Devices [Lip Retractor]

• 07333117000179: LR-00-02
• 07333117000162: LR-00-01