FDA.reportPublic FDA data

Proback Towels

Primary DI
00732224004044
Brand
Proback Towels
Company
CROSSTEX INTERNATIONAL, INC.
Model
WEPBYE
Device description
Towels Bulk Extra Heavy Tissue Plus Poly 19 in x 13 in, Yellow
Published
2022-10-31
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHRABSORBER, SALIVA, PAPER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224004049PrimaryGS10
00732224004044Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400404950732224004049
00732224004044007322240040447322240040440732224004044

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
057728685
Device count
500
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10732224000050Crosstex InternationalSCMSCM2016-11-11
30732224120233Isofluid Surgical MasksGCIPWBGCIPWB2016-11-11
50732224005008Safe-Flo Plus Saliva EjectorM1002WHWHM1002WHWH2024-11-22
50732224004988Safe-Flo Plus Saliva EjectorM1003CLWHM1003CLWH2024-11-22
50732224005015Safe-Flo Plus Saliva EjectorM1004WHGRM1004WHGR2024-11-22
50732224005022Safe-Flo Plus Saliva EjectorM1005WHPKM1005WHPK2024-11-22
00732224005508DentaPure 365-Day Independent Water Bottle Cartridge*DP365B102022-11-21
00732224005515DentaPure Water Purification Municipal Cartridge*DP365M102022-11-21
00732224005522DentaPure Water Purification Bottle Cartridge*DP40B102022-11-21
00732224005690CrosstexZFFAD-100ZFFAD-1002024-04-19
00732224721484Sporview 10 Hour Self Contained BISVT-504SVT-5042024-04-10
20815878025321Burkhart Non-Woven SpongesENCNWLBK2024-04-09
20815878027585Burkhart Non-Woven SpongesENC100BK2024-04-09
20815878027592Burkhart Cotton RollsDNACBK2024-04-09
20815878028483Burkhart Non-Woven SpongesENC4NWLBK2024-04-09
10732224005673DentaPure Water Purification Bottle CartridgeDPI365B2024-04-08
10732224005680DentaPure Water Purification Municipal CartridgeDPI365M2024-04-08
00732224005676DentaPure Water Purification Bottle CartridgeDPI365B102024-04-08
00732224005683DentaPure Water Purification Municipal CartridgeDPI365M102024-04-08
10732224001736Articulating PaperTPTH2022-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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