FemCerv 03139

GUDID 00859500005066

FemCerv, Endocervical Sampler, 11 Fr, 10-pack

FEMASYS INC.

Cervical cytology brush

• Primary Device ID: 00859500005066
• NIH Device Record Key: 6c5ba935-6ea3-434c-b929-c84b8cb364a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemCerv
• Version Model Number: FCV-011
• Catalog Number: 03139
• Company DUNS: 147590330
• Company Name: FEMASYS INC.
• Device Count: 10
• 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: true
• Expiration Date: true
• 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	00859500005066 [Unit of Use]
GS1	20859500005060 [Primary]
GS1	30859500005067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122658

FDA Product Code

• PCF: Sampler, Endocervical

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: 2022-09-29
• Device Publish Date: 2022-09-21

On-Brand Devices [FemCerv]

• 00859500005066: FemCerv, Endocervical Sampler, 11 Fr, 10-pack
• 00859500005059: FemCerv, Endocervical Sampler, 13 Fr, 10-pack
• 10859500005063: FemCerv, Endocervical Sampler, 11 Fr, 1-pack
• 10859500005056: FemCerv, Endocervical Sampler, 13 Fr, 1-pack