FDA UDI
In Commercial Distribution
🇺🇸 United States
PATTERSON
DI: D6620708296302
·
Model: 070829630
·
PATTERSON DENTAL SUPPLY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- PATTERSON
- Primary DI
- D6620708296302
- Version / Model
- 070829630
- Company Name
- PATTERSON DENTAL SUPPLY, INC.
- Labeler DUNS
- 171843584
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2017-03-14
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 84b95937-586e-42cf-9d17-804295d7f1bf
Device Description
APEX LOCATOR APRON CLASP 3/PK
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LQY | Locator, Root Apex | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16355 | Endodontic apex locator | A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D6620708296302 | HIBCC | ||||
| Unit of Use | D6620708296300 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101177 | 000 |