FDA UDI
In Commercial Distribution
🇺🇸 United States
Trillium Compression Hook Pliers
DI: 07540295000437
·
Model: 07540295000437
·
Hespeler Orthodontics Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Trillium Compression Hook Pliers
- Primary DI
- 07540295000437
- Version / Model
- 07540295000437
- Company Name
- Hespeler Orthodontics Limited
- Labeler DUNS
- 203297635
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-09
- Public Version
- 1
- Public Version Date
- 2024-08-19
- Public Version Status
- New
- Public Device Record Key
- 031fc73e-2454-4347-a7c9-2ef105b7a479
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JEX | Plier, Orthodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33209 | Orthodontic pliers | A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540295000437 | GS1 | ||||
| Previous | 75402950900043 | GS1 |