FDA UDI
In Commercial Distribution
🇺🇸 United States
Health-Tec Chair Sleeves
DI: D773660HT275241
·
Model: 660-HT27524
·
Dental Health Products Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
225
Basic Information
- Brand Name
- Health-Tec Chair Sleeves
- Primary DI
- D773660HT275241
- Version / Model
- 660-HT27524
- Catalog Number
- 660-HT27524
- Company Name
- Dental Health Products Inc
- Labeler DUNS
- 623191194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 225
- Record Status
- Published
- Publish Date
- 2017-01-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1c591782-5fa3-4dd0-b3c2-ff3b6db41c82
Device Description
Health-Tec Chair Sleeves, 27.5" x 24"
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 |
|---|---|---|---|---|
| 61049 | Instrument/equipment drape, single-use, non-sterile | A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D773660HT275241 | HIBCC | ||||
| Unit of Use | D773660HT275240 | HIBCC | ||||
| Package | D773660HT275243 | HIBCC | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-626-2163
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160232 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 27.5" x 24" |