FDA.reportPublic FDA data

Crosstex Disposable Face Shields

Primary DI
50732224000942
Brand
Crosstex Disposable Face Shields
Company
CROSSTEX INTERNATIONAL, INC.
Model
GCSS9
Device description
Face Shield, Full Length (9") Clear
Published
2022-08-19
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
FYEDRESS, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYEDress, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224000942PackageGS16In Commercial Distribution
10732224000944PrimaryGS10
00732224000947Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400094250732224000942
1073222400094410732224000944
00732224000947007322240009477322240009470732224000947

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
057728685
Device count
18
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
10732224002993Bite Wing-Ease™ Barrier SleevesBWES2022-09-29
10732224003044Slip-Ease™ CushionsBWSEL2022-09-29
10732224003068Wrap-Ease™ CushionsBWWEL2022-09-29
10732224003549Advantage Plus Cotton Tipped ApplicatorsH3AC2022-08-19
10732224003556Advantage Plus Cotton Tipped ApplicatorsH6AC2022-08-19
10732224120499Surgical Tie-On MaskGCS2022-05-06
50732224001291Polyback™ TowelsWPXFP2022-10-31
50732224001321Polyback™ TowelsWPXTB2022-10-31
50732224002359Econoback™ TowelsWEXFP2022-10-31
50732224002366Econoback™ TowelsWEXTB2022-10-31
50732224003936Non-Woven Headrest coversL3CB2022-09-29
50732224004841Professional Regular TowelsWTXFPWTXFP2023-07-17
30732224001136Self-Sealing Sterilization BagOCS2022-05-03
50732224005206Premium Non-Woven SpongesENCNW4KENCNW4K2025-10-23
50732224001086Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2025-10-23
10732224001088Ultra Gauze Non-Woven SpongesENCNWUBENCNWUB2022-08-25
10732224005208Premium Non-Woven SpongesENCNW4KENCNW4K2023-07-17
50732224000140Sani Vac Evacuation System CleanerJVACSAMPLESJVACSAMPLES2022-08-19
10732224110568Duo-Check Self-Sealing Sterilization PouchesSCM2025-07-24
10732224000050Crosstex InternationalSCMSCM2016-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810100050313KBMEDKB Medical (group), Inc.FYE2025-05-22
00810100050320KBMEDKB Medical (group), Inc.FYE2025-05-22
00810100050337KBMEDKB Medical (group), Inc.FYE2025-05-22
00810100050344KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050310KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050327KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050334KBMEDKB Medical (group), Inc.FYE2025-05-22
10810100050341KBMEDKB Medical (group), Inc.FYE2025-05-22
10097604601129Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
10097604603345Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
00097604601122Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
00097604603348Tronex International, Inc.TRONEX INTERNATIONAL, INC.FYE2022-10-28
06970645860113YINGJIAJiangsu Jiawen Medical Supplies Co.,Ltd.FYE2022-10-20
10732224000920Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
10732224000944Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000935Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000959Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
50732224000928Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
00732224000930Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
00732224000954Crosstex Disposable Face ShieldsCROSSTEX INTERNATIONAL, INC.FYE2022-08-19
10889950134136Crosstex™HU-FRIEDY MFG. CO., LLCFYE2022-03-11
00813360021390ProtexerICP MEDICAL, LLCFYE2022-02-03
10813360021397ProtexerICP MEDICAL, LLCFYE2022-02-03
10653160317609CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFYE2022-01-01
00653160317602CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFYE2022-01-01
10653160217626Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.FYE2021-09-02
40653160217627Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.FYE2021-09-02
B086105051Protect U Guard CPE Isolation GownPROTECT U GUARD, LLCFYE2021-02-02
06944414040914MED-LINKShenzhen Med-Link Electronics Tech Co.,Ltd.FYE2020-05-07
10603295326359LIFE LINERDEPUY ORTHOPAEDICS, INC.FYE2018-09-24