Identity
- Trade Name
- QUIKsheath Barriers Scaler/Instrument FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- 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" FDA UDI
- Model / Reference
- 7019723 FDA UDI
- 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" FDA UDI
Identifiers
- Catalog Number
- 7019723 FDA UDI
- Primary DI / UDI-DI
- 00723896009727 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical equipment/instrument drape, single-use
QUIKsheath Barriers Scaler/Instrument by Practicon, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Practicon, Inc.
Sources (1)
- FDA UDI 9b46ea76-8c0b-4ffd-9b3c-59163daed08a 34 fields · synced May 30, 2026