Pap Perfect

GUDID 20888937003165

Plastic cervical scrapers

Coopersurgical, Inc.

Papanicolaou smear kit

• Primary Device ID: 20888937003165
• NIH Device Record Key: 43e6cc04-4689-41bf-a428-04c1ac60f1c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pap Perfect
• Version Model Number: 11080
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: 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	20888937003165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861389

FDA Product Code

• HHT: Spatula, Cervical, Cytological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

Devices Manufactured by Coopersurgical, Inc.

• 60888937029798 - ORIGIO Gradient 90 w/o Gentamicin: 2026-03-20 ORIGIO Gradient 90 w/o Gentamicin 5x60 ml
• 00888937028331 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast. 10 ml
• 00888937028348 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast 60 ml
• 00888937028355 - ORIGIO Sequential Blast: 2026-02-13 ORIGIO Sequential Blast with phenol red. 10 ml
• 00888937028386 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav. 10 ml
• 00888937028393 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav. 60 ml
• 00888937028409 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav with phenol red. 10 ml
• 00888937028416 - ORIGIO Sequential Cleav: 2026-02-13 ORIGIO Sequential Cleav with phenol red. 60 ml