FDA UDI
In Commercial Distribution
🇺🇸 United States
PRACTIfilm Barrier Cling Sheets Blue
DI: 00723896018163
·
Model: 704223 4X6 Blue Film
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1200
Basic Information
- Brand Name
- PRACTIfilm Barrier Cling Sheets Blue
- Primary DI
- 00723896018163
- Version / Model
- 704223 4X6 Blue Film
- Catalog Number
- 704223
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1200
- Record Status
- Published
- Publish Date
- 2020-08-14
- Public Version
- 1
- Public Version Date
- 2020-08-24
- Public Version Status
- New
- Public Device Record Key
- 64a79b46-a2e2-408c-b7f1-8857d1929ffc
Device Description
Blue PRACTIfilm Barrier Cling Sheets are a simple solution to contamination control. Thinner 1.5 mil polyethylene and special low-tack adhesive give PRACTIfilm the ideal cling quality. Each 4" x 6" sheet sticks anywhere yet removes easily, leaving no residue. 1,200 perforated sheets per roll in a convenient dispenser box.
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
- 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 | 00723896018170 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00723896018163 | GS1 | ||||
| Unit of Use | 00723896018156 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151123 | 000 |