FDA UDI
In Commercial Distribution
🇺🇸 United States
TELIGEN
DI: 10705034560359
·
Model: 186000000S
·
Medos International Sàrl
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TELIGEN
- Primary DI
- 10705034560359
- Version / Model
- 186000000S
- Catalog Number
- 186000000S
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-01
- Public Version
- 2
- Public Version Date
- 2024-02-12
- Public Version Status
- Update
- Public Device Record Key
- 5e696ca9-f9d5-4663-a373-0ef7d92b90c0
Device Description
TELIGEN Procedure Kit Pro
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| PDQ | Neurosurgical nerve locator | Ear, Nose, Throat | 874.1820 | 2 |
| LXH | Orthopedic manual surgical instrument | Orthopedic | 888.4540 | 1 |
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
| GAD | RETRACTOR | General, Plastic Surgery | 878.4800 | 1 |
| OLO | Orthopedic stereotaxic instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44052 | Orthopaedic surgical procedure kit, non-medicated, single-use | A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10705034560359 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]