FDA UDI
In Commercial Distribution
🇺🇸 United States
Health-Tec Light Handle Sleeves
DI: D773660HT45751
·
Model: 660-HT4575
·
Dental Health Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
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Basic Information
- Brand Name
- Health-Tec Light Handle Sleeves
- Primary DI
- D773660HT45751
- Version / Model
- 660-HT4575
- Catalog Number
- 660-HT4575
- Company Name
- Dental Health Products Inc
- Labeler DUNS
- 623191194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2017-01-24
- Public Version
- 5
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- e46519ce-920f-46ad-8542-9daf263c65de
Device Description
Health-Tec Light Handle Sleeves, 4" x 5.75"
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
- No
- 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 |
|---|---|---|---|---|
| 44977 | Medical equipment handle cover, single-use | A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D773660HT45751 | HIBCC | ||||
| Unit of Use | D773660HT45750 | HIBCC | ||||
| Package | D773660HT45753 | HIBCC | 36 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-626-2163
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160232 | 000 |