SCHEU-Anchor

GUDID J01820510

SCHEU-Anchor Ø 0.9 mm

Scheu-Dental GmbH

Orthodontic wire

• Primary Device ID: J01820510
• NIH Device Record Key: bbd93663-1ef3-4767-a1c3-43d10b651721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCHEU-Anchor
• Version Model Number: 2051.3
• Company DUNS: 317683787
• Company Name: Scheu-Dental GmbH
• Device Count: 1000
• 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: 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
HIBCC	J01820510 [Unit of Use]
HIBCC	J01820511 [Primary]
HIBCC	J01820512 [Primary]
HIBCC	J01820513 [Primary]

FDA Product Code

• EHP: Clasp, Preformed

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: 2024-11-27
• Device Publish Date: 2024-11-19

On-Brand Devices [SCHEU-Anchor]

• J01820530: SCHEU-Anchor Ø 1.2 mm
• J01820520: SCHEU-Anchor Ø 1.0 mm
• J01820510: SCHEU-Anchor Ø 0.9 mm
• J01820500: SCHEU-Anchor Ø 0.8 mm
• J01820490: SCHEU-Anchor Ø 0.7 mm
• J01820480: SCHEU-Anchor Ø 0.6 mm