FDA UDI
In Commercial Distribution
🇺🇸 United States
TEMPUR-PEDIC PERINEAL POST PAD 6 IN
DI: 00842430100208
·
Model: 3369-1
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TEMPUR-PEDIC PERINEAL POST PAD 6 IN
- Primary DI
- 00842430100208
- Version / Model
- 3369-1
- Catalog Number
- 3369-1
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-30
- Public Version
- 3
- Public Version Date
- 2020-03-23
- Public Version Status
- Update
- Public Device Record Key
- 028ce037-51c8-401e-a3af-c8a0346c9261
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41675 | Surgical counter-traction post | A cylindrical rod designed to be attached to an operating table or extension device to function as a support to counter the pulling of the traction being applied to a patient's body part (e.g., leg, pelvis) during an orthopaedic surgical procedure (e.g., hip arthroplasty, pelvic reconstruction); it is typically placed against the perineal region [referred to as perineal post] or leg bones (e.g., femur, tibia). It is available in various diameters and lengths and is typically padded. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430100208 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 38 Degrees Celsius