FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 07613327175387
·
Model: 4701
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 07613327175387
- Version / Model
- 4701
- Catalog Number
- 4701-045-010
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 078470558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a21c533e-d2b7-4cb5-925e-5031f6dec75b
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HDD | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) | Obstetrics/Gynecology | 884.4900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15732 | Birthing bed/table, powered | An electrically-powered, adjustable device designed to support a pregnant woman's body in an appropriate position during labour and delivery, and may in addition be intended for other obstetrical examination or treatment procedures. This device may be referred to as a birthing/obstetric bed, table, couch, or chair, and will typically include, leg holders (stirrups), traction handles, a receptacle for afterbirth, and have facilities for the attachment of different accessories. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327175387 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K950889 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 104 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- -4 – 104 Degrees Fahrenheit
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 KiloPascal