FemCerv 03137

GUDID 10859500005063

FemCerv, Endocervical Sampler, 11 Fr, 1-pack

FEMASYS INC.

Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush Cervical cytology brush

• Primary Device ID: 10859500005063
• NIH Device Record Key: 36fda73b-c038-4f4d-b8ac-86bcfd05da2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemCerv
• Version Model Number: FCV-011
• Catalog Number: 03137
• Company DUNS: 147590330
• Company Name: FEMASYS 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: 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	10859500005063 [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