DIAMENDO A016532500200

GUDID J003A0165325002001

Dental burs

MAILLEFER INSTRUMENTS HOLDING Sàrl

Diamond dental bur, reusable Diamond dental bur, reusable Diamond dental bur, reusable Diamond dental bur, reusable Diamond dental bur, reusable Diamond dental bur, reusable Diamond dental bur, reusable Diamond dental bur, reusable Diamond dental bur, reusable Diamond dental bur, reusable Diamond dental bur, reusable

• Primary Device ID: J003A0165325002001
• NIH Device Record Key: fd34a84b-2e3c-4913-a7f0-ef009aa10431
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIAMENDO
• Version Model Number: A016532500200
• Catalog Number: A016532500200
• Company DUNS: 480538495
• Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A
• Special Storage Condition, Specify: Between 0 and 0 *N/A

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J003A0165325002001 [Primary]

FDA Product Code

• DZP: INSTRUMENT, DIAMOND, 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: 2022-11-28
• Device Publish Date: 2022-11-20

On-Brand Devices [DIAMENDO]

• J003A0165325002001: Dental burs
• J003A0165321001001: Dental burs