FDA UDI
In Commercial Distribution
🇺🇸 United States
SOS
DI: 05060388740009
·
Model: FP-010
·
SAFE OBSTETRIC SYSTEMS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- SOS
- Primary DI
- 05060388740009
- Version / Model
- FP-010
- Catalog Number
- FP-010
- Company Name
- SAFE OBSTETRIC SYSTEMS LIMITED
- Labeler DUNS
- 365370241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-10
- Public Version
- 3
- Public Version Date
- 2021-08-02
- Public Version Status
- Update
- Public Device Record Key
- d13cfe11-4d98-4f85-9b78-34f84bd8eae7
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PWB | Fetal Head Elevator | Obstetrics/Gynecology | 884.4350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34988 | Birthing/delivery kit | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060388740009 | GS1 | ||||
| Package | 05060388740023 | GS1 | sterile | 6 | Not in Commercial Distribution | 2021-07-31 |
| Package | 25060388740003 | GS1 | Box | 6 | In Commercial Distribution | |
| Package | 35060388740000 | GS1 | Case | 24 | In Commercial Distribution |