FDA.reportPublic FDA data

Crosstex™

Primary DI
10889950134136
Brand
Crosstex™
Company
HU-FRIEDY MFG. CO., LLC
Model
SP-GFS
Device description
Face Shield Sample Pack
Published
2022-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10889950134136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088995013413610889950134136

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-7433info@hu-friedy.com

Regulatory Flags#

DUNS number
005085972
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889950157326Hu-FriedyIMNO24511C2026-05-26
10889950147020Hu-FriedyDSBH5/662026-04-17
10889950157180Hu-FriedyIM40580-C42026-04-07
10889950157197Hu-FriedyIMN9142HAS2026-04-07
10889950126339Hu-Friedy MFG Co., LLC.CLAWXS2026-04-06
10889950126346Hu-Friedy MFG Co., LLC.CLAWS2026-04-06
10889950126353Hu-Friedy MFG Co., LLC.CLAWM2026-04-06
10889950126360Hu-Friedy MFG Co., LLC.CLAWL2026-04-06
10889950126377Hu-Friedy MFG Co., LLC.CLAWXL2026-04-06
10889950126384Hu-Friedy MFG Co., LLC.CLAWXSX2026-04-06
10889950126391Hu-Friedy MFG Co., LLC.CLAWSX2026-04-06
10889950126407Hu-Friedy MFG Co., LLC.CLAWMX2026-04-06
10889950126414Hu-Friedy MFG Co., LLC.CLAWLX2026-04-06
10889950126421Hu-Friedy MFG Co., LLC.CLAWXLX2026-04-06
10889950001643Hu-Friedy Mfg. Co., LLCPSN6953LPSN6953L2015-10-16
10889950001834Hu-Friedy Mfg. Co., LLCPSN7773LPSN7773L2015-10-16
10889950002060Hu-Friedy Mfg. Co., LLCPSNR683LPSNR683L2015-10-16
10889950002077Hu-Friedy Mfg. Co., LLCPSNR698LPSNR698L2015-10-16
10889950002084Hu-Friedy Mfg. Co., LLCPSNR7772LPSNR7772L2015-10-16
10889950156008Hu-FriedyIM53FMC22026-03-05

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
50732224000942Crosstex 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
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