FDA.report

Crosstex Ultra-Gauze Non-Woven Sponges Non-Sterile, 4-Ply

Primary DI
50732224001086
Brand
Crosstex Ultra-Gauze Non-Woven Sponges Non-Sterile, 4-Ply
Company
CROSSTEX INTERNATIONAL, INC.
Model
ENCNWUB
Device description
Non-Woven Sponges, 2 in x 2 in / 5.1 cm x 5.1 cm
Published
2022-08-25
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

Contact Domains

Product Codes

CodeName
EFNCOTTON, ROLL
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
EFNCotton, RollDental1
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50732224001086PackageGS140In Commercial Distribution
10732224001088PrimaryGS10
00732224001081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5073222400108650732224001086
1073222400108810732224001088
00732224001081007322240010817322240010810732224001081

GMDN Terms

TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(585)359-0167regulatoryaffairs@hu-friedy.com
+1(800)483-7433care@hu-friedy.com

Regulatory Flags

DUNS number
057728685
Device count
200
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 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 DIBrandCompanyProduct codePublished
06979109839986GAUZE SWABSXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-03-16
20763000888989MerocelMEDTRONIC XOMED, INC.NAB2026-03-08
20763000888996MerocelMEDTRONIC XOMED, INC.NAB2026-03-08
00851587006073XGAUZE Trauma PadRevmedx, Inc.NAB2026-02-25
20665973020918DukalDukal LLCNAB2026-01-30
20665973020932DukalDukal LLCNAB2026-01-30
00810194401763AiraAIRA, LLCNAB2026-01-16
00810194401770AiraAIRA, LLCNAB2026-01-16
00810194401787AiraAIRA, LLCNAB2026-01-16
00810194401794AiraAIRA, LLCEFN2026-01-16
00810194401824AiraAIRA, LLCNAB2026-01-16
00810194401831AiraAIRA, LLCNAB2026-01-16
00810194401848AiraAIRA, LLCNAB2026-01-16
00810194401855AiraAIRA, LLCNAB2026-01-16
00723896029558Practicon® Standard 2x2 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029589Practicon® Premium 2x2 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029619Practicon® Standard 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00723896029640Practicon® Premium 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
00840456217009JMUJMU DENTAL, INCNAB2025-12-31
00840456217856JMUJMU DENTAL, INCNAB2025-12-31
00840456217863JMUJMU DENTAL, INCNAB2025-12-31
06931918102354AllesetGRI Medical & Electronic Technology Co., Ltd.NAB2025-12-16
10815555025593CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025609CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025715CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025616CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025692CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
10815555025708CypressMCKESSON MEDICAL-SURGICAL INC.NAB2025-12-16
08809968572930Soosung Non-Woven Fabricsoosung medicalNAB2025-12-10
08809968572954Soosung Non-Woven Fabricsoosung medicalNAB2025-12-10