FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10886705017089
·
Model: 284107
·
DEPUY MITEK, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10886705017089
- Version / Model
- 284107
- Catalog Number
- 284107
- Company Name
- DEPUY MITEK, LLC
- Labeler DUNS
- 190572854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-04
- Public Version
- 4
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- c1adc1b8-93d8-4138-bba4-fe6bfd638122
Device Description
Hand Control Interface LINVATEC ApeX
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRX | ARTHROSCOPE | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36224 | Arthroscopic shaver system, electrically-powered | A dedicated assembly of electrically-powered devices designed for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It typically consists of a power supply/control unit with operational display and dedicated software, intended to provide optimal parameters for the procedure, and a rotatory handpiece(s) that can operate a variety of burs and blades (either straight or curved) or other rotatory instruments. An irrigation system may be included. Common procedures include cartilage debridement (e.g., meniscus repair or meniscectomy) and removal of the inflamed inner lining of the joint (synovectomy). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886705017089 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K954465 | 000 |