FDA UDI
Not in Commercial Distribution
🇺🇸 United States
UNiD_PASS
DI: 03613720268697
·
Model: B33225512-08
·
MEDICREA INTERNATIONAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UNiD_PASS
- Primary DI
- 03613720268697
- Version / Model
- B33225512-08
- Catalog Number
- B33225512-08
- Company Name
- MEDICREA INTERNATIONAL
- Labeler DUNS
- 383228632
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-12
- Public Version
- 6
- Public Version Date
- 2022-05-23
- Public Version Status
- Update
- Public Device Record Key
- d978375f-6ac2-4a08-bc95-d33af1af11fb
- Distribution End Date
- 2021-08-18
Device Description
UNiD CoCr Rod Ø5.5mm - 08
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61325 | Bone-screw internal spinal fixation system, non-sterile | An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03613720268697 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140738 | 000 |