FDA UDI
In Commercial Distribution
🇺🇸 United States
OrthoLite™ Instruments
DI: 00190707089221
·
Model: 201-502W
·
ORTHO ORGANIZERS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OrthoLite™ Instruments
- Primary DI
- 00190707089221
- Version / Model
- 201-502W
- Company Name
- ORTHO ORGANIZERS, INC.
- Labeler DUNS
- 062165188
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-13
- Public Version
- 1
- Public Version Date
- 2021-09-21
- Public Version Status
- New
- Public Device Record Key
- 707b336a-9101-4bd4-97bf-78ba824e0dd2
Device Description
OrthoLite™ 3/8" Ligature Director/Scaler
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
- Yes
- 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 | 00190707089221 | GS1 |