FDA UDI
In Commercial Distribution
🇺🇸 United States
Denticator
DI: 00816577024628
·
Model: 670350
·
YOUNG DENTAL MANUFACTURING I, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Denticator
- Primary DI
- 00816577024628
- Version / Model
- 670350
- Catalog Number
- 670350
- Company Name
- YOUNG DENTAL MANUFACTURING I, LLC
- Labeler DUNS
- 006309355
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-30
- Public Version
- 2
- Public Version Date
- 2025-01-20
- Public Version Status
- Update
- Public Device Record Key
- ae98175d-6147-4752-8887-74e0cec4f453
Device Description
Denticator Light Handle Sleeve, Infection Control Barrier
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
- No
- 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 |
|---|---|---|---|---|
| PEM | Dental barriers and sleeves | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816577024625 | GS1 | Inner Pack | 1 | In Commercial Distribution | |
| Primary | 00816577024628 | GS1 |
Customer Contacts
- Phone
- +1(800) 325-1881
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233918 | 000 |