FDA UDI
In Commercial Distribution
🇺🇸 United States
Consensus Hip System
DI: 00840286803083
·
Model: 1017-0-1060
·
Shalby Advanced Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Consensus Hip System
- Primary DI
- 00840286803083
- Version / Model
- 1017-0-1060
- Catalog Number
- 1017-0-1060
- Company Name
- Shalby Advanced Technologies, Inc.
- Labeler DUNS
- 085976260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-15
- Public Version
- 1
- Public Version Date
- 2022-01-24
- Public Version Status
- New
- Public Device Record Key
- ad6b181b-5a22-4786-80be-ef831ee8663c
Device Description
Unipolar Head, 60mm, ±0mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KWL | Prosthesis, hip, hemi-, femoral, metal | Orthopedic | 888.3360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33175 | Metallic femoral head prosthesis | An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840286803083 | GS1 |
Customer Contacts
- Phone
- +1(916)355-7100 ext. 155
- [email protected]