FDA UDI
In Commercial Distribution
🇺🇸 United States
OrthoMedFlex
DI: M716AC3560
·
Model: AC-356
·
ORTHOMEDFLEX LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OrthoMedFlex
- Primary DI
- M716AC3560
- Version / Model
- AC-356
- Catalog Number
- AC-356
- Company Name
- ORTHOMEDFLEX LLC
- Labeler DUNS
- 034442726
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-08
- Public Version
- 3
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- bd0ec531-a4b7-467f-b9db-0f5d72987687
Device Description
Tryon Acetabular Cup, Size 56mm, Multi Hole - Ti6AI4V Alloy with Porous Coating
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
- Yes
- 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 |
|---|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43167 | Acetabular shell | An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M716AC3560 | HIBCC |
Customer Contacts
- Phone
- 18446633539
- [email protected]