Acu-Dispo-Curette

GUDID 00814105020043

Acu-Dispo-Curette 5mm, Single

ACUDERM, INC.

Dermal curette

• Primary Device ID: 00814105020043
• NIH Device Record Key: 58c5d059-f7c7-4f0a-855d-38b4ade0c431
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acu-Dispo-Curette
• Version Model Number: R05
• Company DUNS: 071426803
• Company Name: ACUDERM, INC.
• Device Count: 1
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814105020043 [Primary]
GS1	10814105020040 [Package]; Package: Box [25 Units]; In Commercial Distribution
GS1	20814105020047 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	30814105020044 [Package]; Package: Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891334

FDA Product Code

• FZS: Curette, Surgical, General Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-30
• Device Publish Date: 2020-09-22

On-Brand Devices [Acu-Dispo-Curette]

• 00814105021323: Acu-Dispo-Curette, Plus Assortment
• 00814105021316: Acu-Dispo-Curette Combo
• 00814105020050: Acu-Dispo-Curette 7mm, Single
• 00814105020043: Acu-Dispo-Curette 5mm, Single
• 00814105020036: Acu-Dispo-Curette 4mm, Single
• 00814105020029: Acu-Dispo-Curette 3mm, Single
• 00814105020012: Acu-Dispo-Curette 2mm, Single
• 00814105020005: Acu-Dispo-Curette 1mm cup