FDA UDI
In Commercial Distribution
🇺🇸 United States
DENALI
DI: 00810042120488
·
Model: MUA4-410
·
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DENALI
- Primary DI
- 00810042120488
- Version / Model
- MUA4-410
- Company Name
- ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
- Labeler DUNS
- 077801124
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-21
- Public Version
- 1
- Public Version Date
- 2020-04-29
- Public Version Status
- New
- Public Device Record Key
- 52af3193-d27c-4b92-aaf0-e7ba6b63c10f
Device Description
Perry Tweezer - Curved Tip
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCX | Epilator, High Frequency, Tweezer-Type | General, Plastic Surgery | 878.5360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31814 | Dental dressing forceps, reusable | A hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810042120488 | GS1 |