FDA.reportPublic FDA data

Crosstex International

Primary DI
10732224110438
Brand
Crosstex International
Company
CROSSTEX INTERNATIONAL, INC.
Model
SW48
Catalog number
SW48
Device description
48X48 CSR WRAP
Published
2016-10-13
Public version status
Update
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
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10732224110438PrimaryGS10
00732224110431Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073222411043810732224110438
00732224110431007322241104317322241104310732224110431

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)276-7783crosstex@crosstex.com
+1(585)359-0167regulatoryaffairs@hu-friedy.com

Regulatory Flags#

DUNS number
057728685
Device count
50
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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

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Primary DI, Brand, Company table
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00810194400896AiraAIRA, LLCFRG2026-01-16
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06438263667250Steriking®Wipak OyFRG2025-12-30
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