FDA UDI
In Commercial Distribution
🇺🇸 United States
Rexall
DI: 00850019681857
·
Model: 10686401
·
DOLGENCORP, LLC
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Rexall
- Primary DI
- 00850019681857
- Version / Model
- 10686401
- Company Name
- DOLGENCORP, LLC
- Labeler DUNS
- 068331990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2020-11-09
- Public Version
- 1
- Public Version Date
- 2020-11-17
- Public Version Status
- New
- Public Device Record Key
- 10f1f118-0e46-436d-8e54-f65f46f123ea
Device Description
Rexall Pick and Mirror Set
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| EAX | Mirror, Mouth | Dental | 872.4565 | 1 |
| EMQ | Hoe, Periodontic | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31908 | Periodontal hoe | A hand-held manual dental instrument with a small blade at an acute angle (e.g., 90 degrees) to its stem intended to be used with a pulling action to remove gross amounts of supragingival calculus, and some subgingival calculus, in large wide-open pockets where the gingival tissue is soft and easily cleaned. It is usually made of high-grade stainless steel. This is a reusable device. | No | Active |
| 31776 | Dental mirror, reusable | A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 50850019681852 | GS1 | ||||
| Primary | 00850019681857 | GS1 |