SOS FP-010

GUDID 05060388740009

Fetal Pillow is a Single-use,sterile fetal head elevator consisting of a mechanism that elevates the fetal head to facilitate delivery during a Cesarean Section.Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Cesarean Section at full dilation or those requiring a Cesarean Section after a failed instrumental vaginal delivery.

SAFE OBSTETRIC SYSTEMS LIMITED

Birthing/delivery kit

• Primary Device ID: 05060388740009
• NIH Device Record Key: d13cfe11-4d98-4f85-9b78-34f84bd8eae7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOS
• Version Model Number: FP-010
• Catalog Number: FP-010
• Company DUNS: 365370241
• Company Name: SAFE OBSTETRIC SYSTEMS LIMITED
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	05060388740009 [Primary]
GS1	05060388740023 [Package]; Package: sterile [6 Units]; In Commercial Distribution
GS1	25060388740003 [Package]; Package: Box [6 Units]; In Commercial Distribution
GS1	35060388740000 [Package]; Package: Case [24 Units]; In Commercial Distribution

FDA Product Code

• PWB: Fetal Head Elevator

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: 2019-12-18
• Device Publish Date: 2019-12-10