SOS

Primary DI
05060388740009
Brand
SOS
Company
SAFE OBSTETRIC SYSTEMS LIMITED
Model
FP-010
Catalog number
FP-010
Device description
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.
Published
2019-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PWBFetal Head Elevator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWBFetal Head ElevatorObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060388740023PackageGS16In Commercial Distribution
25060388740003PackageGS16In Commercial Distribution
35060388740000PackageGS124In Commercial Distribution
05060388740009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060388740023050603887400235060388740023
2506038874000325060388740003
3506038874000035060388740000
05060388740009050603887400095060388740009

GMDN Terms#

Term, Definition table
TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
365370241
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true