FDA UDI In Commercial Distribution 🇺🇸 United States

QUIKsheath Barriers Low-Speed Straight

DI: 00723896009680 · Model: 70-19721 · PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
500

Basic Information

Brand Name
QUIKsheath Barriers Low-Speed Straight
Primary DI
00723896009680
Version / Model
70-19721
Catalog Number
70-19721
Company Name
PRACTICON, INC.
Labeler DUNS
119193803
Distribution Status
In Commercial Distribution
Device Count in Pkg
500
Record Status
Published
Publish Date
2018-07-12
Public Version
2
Public Version Date
2023-06-13
Public Version Status
Update
Public Device Record Key
d8493550-2847-4073-87d5-1ff587cb6c6b

Device Description

educe contamination and cleanup time between patients for only pennies per sheath. Unique pre-punched design pulls over handpieces more easily for an effective barrier. Provides visual assurance of aseptic procedures. Measures approximately 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
PEM Dental Barriers And Sleeves

GMDN Terms

Code Name
12535 Medical equipment drape, single-use

Identifiers

Type ID
Package 00723896009697
Primary 00723896009680
Unit of Use 00723896003190