FDA.reportPublic FDA data

Sani-Tube Nylon Sterilization Tubing with Process Indicator

Primary DI
50732224110146
Brand
Sani-Tube Nylon Sterilization Tubing with Process Indicator
Company
CROSSTEX INTERNATIONAL, INC.
Model
SI4
Catalog number
SI4
Device description
4 inch x 100 ft roll
Published
2023-07-17
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
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50732224110146PackageGS112In Commercial Distribution
10732224110148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5073222411014650732224110146
1073222411014810732224110148

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. 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
1
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
G476TENZ20X10X2Tenzin SteriZIgn Sterilization TraySterizign Precision Technologies, LLCKCT2026-09-25
00385640094535INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094542INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00385640094559INSTRUSAFESummit Medical, Inc.KCT2026-09-24
00724995237059V. MuellerSteris CorporationKCT2026-09-24
00724995237066V. MuellerSteris CorporationKCT2026-09-24
00724995237073V. MuellerSteris CorporationKCT2026-09-24
00724995237080V. MuellerSteris CorporationKCT2026-09-24
00724995237097V. MuellerSteris CorporationKCT2026-09-24
00724995237103V. MuellerSteris CorporationKCT2026-09-24
00724995237110V. MuellerSteris CorporationKCT2026-09-24
00724995237127V. MuellerSteris CorporationKCT2026-09-24
00724995237134V. MuellerSteris CorporationKCT2026-09-24
00724995237141V. MuellerSteris CorporationKCT2026-09-24
00724995237158V. MuellerSteris CorporationKCT2026-09-24
00724995237165V. MuellerSteris CorporationKCT2026-09-24
00724995237172V. MuellerSteris CorporationKCT2026-09-24
00724995237189V. MuellerSteris CorporationKCT2026-09-24
00724995237196V. MuellerSteris CorporationKCT2026-09-24
00724995237202V. MuellerSteris CorporationKCT2026-09-24
00724995237219V. MuellerSteris CorporationKCT2026-09-24
00724995237226V. MuellerSteris CorporationKCT2026-09-24
00724995237233V. MuellerSteris CorporationKCT2026-09-24
00724995237240V. MuellerSteris CorporationKCT2026-09-24
00724995237257V. MuellerSteris CorporationKCT2026-09-24
00724995237264V. MuellerSteris CorporationKCT2026-09-24
00724995237271V. MuellerSteris CorporationKCT2026-09-24
00724995237288V. MuellerSteris CorporationKCT2026-09-24
00724995237295V. MuellerSteris CorporationKCT2026-09-24
00724995237301V. MuellerSteris CorporationKCT2026-09-24