FDA UDI
In Commercial Distribution
🇺🇸 United States
A. Titan Instruments
DI: 00841685109820
·
Model: XT 136
·
A. TITAN INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- A. Titan Instruments
- Primary DI
- 00841685109820
- Version / Model
- XT 136
- Company Name
- A. TITAN INSTRUMENTS, INC.
- Labeler DUNS
- 037738874
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-19
- Public Version
- 1
- Public Version Date
- 2023-01-27
- Public Version Status
- New
- Public Device Record Key
- d2b31df7-1c6b-4a3f-8e0f-b1bda8813598
Device Description
EASY X-Trac Extraction Screws, 1 peice, 36mm long, Self Cutting, 1.75mm in diameter
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMG | Forceps, Tooth Extractor, Surgical | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35552 | Tooth extraction forceps | A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841685109820 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060691 | 000 |