Acu-Dispo-Curette

GUDID 00814105020043

Acu-Dispo-Curette 5mm, Single

ACUDERM, INC.

Dermal curette Dermal curette Dermal curette Dermal curette Dermal curette Dermal curette Dermal curette Dermal curette Dermal curette Dermal curette Dermal curette Dermal curette Dermal curette 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