FDA UDI
In Commercial Distribution
🇺🇸 United States
Evolve by 3D Dental
DI: 00817169028192
·
Model: EV1UL3
·
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Evolve by 3D Dental
- Primary DI
- 00817169028192
- Version / Model
- EV1UL3
- Catalog Number
- EV1UL3
- Company Name
- 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
- Labeler DUNS
- 080194935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-20
- Public Version
- 2
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 2c002c59-7419-4687-a064-95a4dfe69d0a
Device Description
Evolve Stainless Steel Primary Molar Crowns 1st Upper Left-3 Box Of 5
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| ELZ | Crown, Preformed | Dental | 872.3330 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34979 | Rigid optical culdoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the female peritoneal cavity and organs. It is inserted into the body through a small incision made in the posterior vaginal fornix into the cul-de-sac, also called the rectouterine pouch (pouch of Douglas), during culdoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is used to examine structures of the uterus, ovaries, fallopian tubes, pelvis, and pelvic cavity when the physician is viewing the area from just behind the uterus. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817169028192 | GS1 |