FDA UDI
In Commercial Distribution
🇺🇸 United States
QUIKsheath Barriers Scaler/Instrument
DI: 00723896009727
·
Model: 7019723
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500
Basic Information
- Brand Name
- QUIKsheath Barriers Scaler/Instrument
- Primary DI
- 00723896009727
- Version / Model
- 7019723
- Catalog Number
- 7019723
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2018-07-18
- Public Version
- 2
- Public Version Date
- 2023-06-13
- Public Version Status
- Update
- Public Device Record Key
- 9b46ea76-8c0b-4ffd-9b3c-59163daed08a
Device Description
cut contamination and clean-up time between patients for only pennies per sheath. Unique pre-punched design pulls over instruments and scalers more easily for an effective barrier. Ideal for covering intraoral camera scopes, slimmer handpieces, ultrasonic scalers and pens. Provides visual assurance of aseptic procedures. 9" x 1.5"
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
- No
- Has Manufacturing Date
- No
- 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 drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. 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 | 00723896009734 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00723896009727 | GS1 | ||||
| Unit of Use | 00723896003213 | GS1 |