FDA UDI
In Commercial Distribution
🇺🇸 United States
PLEXUR P®
DI: 00643169218208
·
Model: 60000109
·
MEDTRONIC SOFAMOR DANEK, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PLEXUR P®
- Primary DI
- 00643169218208
- Version / Model
- 60000109
- Company Name
- MEDTRONIC SOFAMOR DANEK, INC.
- Labeler DUNS
- 830350380
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 26ed4d5d-a311-445c-9858-17e06e5788e0
Device Description
CYLINDER 60000109 PLEXUR P 9MMX25MM
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQV | FILLER, BONE VOID, CALCIUM COMPOUND | Orthopedic | 888.3045 | 2 |
| MBP | Filler, bone void, osteoinduction (w/o human growth factor) | Orthopedic | 888.3045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61403 | Cadaveric-donor/synthetic polymer bone graft | A sterile implantable device consisting of processed cadaveric human bone (allograft) mixed with bioabsorbable synthetic polymers, intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is available as granules or various solid shapes in a variety of sizes. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169218208 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080511 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 25.0 | Millimeter | |
| Length | 9.0 | Millimeter |