FDA UDI
In Commercial Distribution
🇺🇸 United States
OrthoMedFlex
DI: M7161111601200
·
Model: 111160120
·
ORTHOMEDFLEX LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OrthoMedFlex
- Primary DI
- M7161111601200
- Version / Model
- 111160120
- Catalog Number
- 111-16-0120
- Company Name
- ORTHOMEDFLEX LLC
- Labeler DUNS
- 034442726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-26
- Public Version
- 2
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 8a4193ea-495f-4f9f-9ed7-d48b156d393c
Device Description
Cement Plug, Size 17mm, LLDPE
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38799 | Polymer orthopaedic cement restrictor, non-bioabsorbable | A non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs (e.g., straight or tapered, hollow with a fenestrated surface), and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and it is not intended for spinal application. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7161111601200 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121297 | 000 |