FDA.report

Quala

Primary DI
D023WEADCEDR3
Brand
Quala
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
WEADCEDR
Catalog number
WEADCEDR
Device description
QUALA TOWEL 2PLY PAPER W/POLY ECONOBK 19X13 DUS ROSE 500/CS
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KHRAbsorber, Saliva, Paper

Product Code Classifications

CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D023WEADCEDR3PrimaryHIBCC0

GMDN Terms

TermDefinition
Patient examination/treatment drape, single-useA non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
009831413
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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M220768003Pro Advantage76800768002025-09-11
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M220769003Pro Advantage76900769002025-09-11
M220770003Pro Advantage77000770002025-09-11
M220P5420025PRO ADVANTAGEP542002P5420022018-09-23
M220P5420075PRO ADVANTAGE P542007P5420072018-09-23
M22P5420105PRO ADVANTAGEP542010P5420102018-09-23
M220P5420125PRO ADVANTAGEP542012P5420122018-09-23
M220P5420155PRO ADVANTAGEP542015P5420152018-09-23
M220P5420175PRO ADVANTAGEP542017P5420172018-09-23
M220P5420205PRO ADVANTAGEP542020P5420202018-09-23
M220P5420225PRO ADVANTAGEP542022P5420222018-09-23
M220P5420255PRO ADVANTAGEP542025P5420252018-09-23
M220P5420275PRO ADVANTAGEP542027P5420272018-09-23
M220P5420295PRO ADVANTAGEP542029P5420292018-09-23
M220P5420305PRO ADVANTAGEP542030P5420302018-09-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810126508201Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKHR2026-03-12
00840456201442JMUJMU DENTAL, INCKHR2025-12-11
00840456201459JMUJMU DENTAL, INCKHR2025-12-11
00840456201466JMUJMU DENTAL, INCKHR2025-12-11
00840456201473JMUJMU DENTAL, INCKHR2025-12-11
00840456201480JMUJMU DENTAL, INCKHR2025-12-11
00840456201497JMUJMU DENTAL, INCKHR2025-12-11
00840456201503JMUJMU DENTAL, INCKHR2025-12-11
00840456201510JMUJMU DENTAL, INCKHR2025-12-11
00840456202753JMUJMU DENTAL, INCKHR2025-12-11
00840456202760JMUJMU DENTAL, INCKHR2025-12-11
00840456202777JMUJMU DENTAL, INCKHR2025-12-11
00840456202784JMUJMU DENTAL, INCKHR2025-12-11
00840456215142JMUJMU DENTAL, INCKHR2025-12-11
00840456215159JMUJMU DENTAL, INCKHR2025-12-11
00840456215609JMUJMU DENTAL, INCKHR2025-12-11
00840456215616JMUJMU DENTAL, INCKHR2025-12-11
00840456217191JMUJMU DENTAL, INCKHR2025-12-11
00840456217207JMUJMU DENTAL, INCKHR2025-12-11
00840456217214JMUJMU DENTAL, INCKHR2025-12-11
00840456217221JMUJMU DENTAL, INCKHR2025-12-11
00840456217238JMUJMU DENTAL, INCKHR2025-12-11
00840456217245JMUJMU DENTAL, INCKHR2025-12-11
00840456217252JMUJMU DENTAL, INCKHR2025-12-11
00840456217269JMUJMU DENTAL, INCKHR2025-12-11
00840456217276JMUJMU DENTAL, INCKHR2025-12-11
00840456217283JMUJMU DENTAL, INCKHR2025-12-11
00840456217290JMUJMU DENTAL, INCKHR2025-12-11
00840456217306JMUJMU DENTAL, INCKHR2025-12-11
00840456217313JMUJMU DENTAL, INCKHR2025-12-11