FDA UDI
In Commercial Distribution
🇺🇸 United States
Ortho Technology
DI: 00190730084743
·
Model: OT-2104
·
ORTHO TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ortho Technology
- Primary DI
- 00190730084743
- Version / Model
- OT-2104
- Company Name
- ORTHO TECHNOLOGY, INC.
- Labeler DUNS
- 781772017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-17
- Public Version
- 1
- Public Version Date
- 2024-09-25
- Public Version Status
- New
- Public Device Record Key
- 0c16bf61-dbff-4bac-90ab-8652df76780c
Device Description
Ligature Director
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| DZN | INSTRUMENTS, DENTAL HAND | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37413 | Orthodontic ligature director | A hand-held dental instrument used to tuck and direct ligatures under the archwire or bracket wings or to push archwires or auxiliaries into position. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190730084743 | GS1 |