Crosstex International CST120

GUDID 50732224000409

ConFirm™ Premium Test Service Mail-in Sterilizer Indicators Monitoring Service, 12 Tests (3 Strip Test, 2 Tests & 1 Control Strip)

CROSSTEX INTERNATIONAL, INC.

Biological sterilization indicator
Primary Device ID50732224000409
NIH Device Record Keyc61db10f-7710-404c-bad0-22f25a98f114
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrosstex International
Version Model NumberCST120
Catalog NumberCST120
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count12
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)276-7783
Emailcrosstex@crosstex.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224000404 [Unit of Use]
GS110732224000401 [Primary]
GS150732224000409 [Package]
Contains: 10732224000401
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRCIndicator, biological sterilization process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-13
Device Publish Date2019-09-04

On-Brand Devices [Crosstex International]

D682GPRN9525Isolator Plus N95 Mask
50732224004162Lead-Free Blue Indicator Steam Tape, 0.71 in X 60 yd (18 mm X 55 m) Roll
50732224004155Lead-Free Blue Steam Indicator Tape, 0.94 in X 60 yd (24 mm X 55 m) Roll
50732224004148Lead-Free Steam Indicator Tape, 0.47 in X 60 yd (12 mm X 55 m) Roll
50732224004131Lead-Free Steam Indicator Tape, 0.71 in X 60 yd (18 mm X 55 m) Roll
50732224004124Lead-Free Steam Indicator Tape, 0.94 in X 60 yd (24 mm X 55 m) Roll
50732224110481(XTEX ADVANTAGE 2.75X9)
50732224110474(POUCH 2.75X9 SELFSEAL)
50732224110467(XTEX 5.25x6.5 SURE CHECK)
50732224110450(XTEX 2.75X9 SURE CHECK)
50732224110092(CROSSTEX 2x8 POUCH)
50732224110085(XTEX 2.25X4 SURE CHECK)
50732224110078(XTEX 2.25X4 STERIL POUCH)
50732224110023(XTEX ADVANTAGE 3.5X5.25)
50732224110009(XTEX 3.5X5.25 INTRNL IND)
50732224109997(POUCH 3.5X5.25 SELFSEAL)
50732224109898(SANI-ROLL 6"-200 M,2/CS)
50732224109881(SANI-ROLL 6- 100' ROLLS)
50732224109867(SANI-ROLL 4"-200 M,4/CS)
50732224109850(SANI-ROLL 4- 100' ROLLS)
50732224109836(SANI-ROLL 3"-200 M,4/CS)
50732224109829(SANI-ROLL 3- 100' ROLLS)
50732224109805(SANI-ROLL 2"-200 M,8/CS)
50732224109799(SANI-ROLL 2- 100' ROLLS)
10732224109784(SANI-ROLL 12"-200 M,1/CS)
50732224109737(PINK PUR POUCH 3.5X9)
50732224109706(CROSSTEX 3.5X9 PCH,500/BX)
50732224109690(XTEX ADVANTAGE 3.5X9)
50732224109676(3.5X9 SURE.CHECK-500/BX)
50732224109669(SURE-CHECK 3.50" x 9", 200/BX - 20/CS)
50732224109621(POUCH 3.5X9 SELFSEAL)
50732224109614(CROSSTEX 3.25X9 SELFSEAL)
50732224109560(PINK PUR POUCH 5.25X10)
50732224109522(XTEX ADVANTAGE 5.25X10)
50732224109515(SURE-CHECK 5.25" x 10", 200/BX - 10/CS)
50732224109454(XTEX 8 X 16 SC POUCH)
50732224109447(CROSSTEX POUCH 8X16)
50732224109423(XTEX 5.25x15 SURE CK PCH)
50732224109416Crosstex Pouch 5.25X15
50732224109409Crosstex 3.5X22 Sure Check
50732224109393Crosstex Pouch 3.5X22
50732224109386(SURE-CHECK 7.50" x 13", 200/BX - 5/CS)
50732224109362Sure-Check 12" x 18", 100/BX - 5/CS
50732224109355Pouch 12X18 Self Seal
50732224109331(XTEX 12 X 15 SURE CHECK)
50732224109324(POUCH 12X15/SELF-SEAL)
50732224109317(CROSSTEX 10.5X17 SURE CHECK)
50732224109294(SURE CHECK 10X15 POUCH)
50732224109287(POUCH 10X15 SELF SEAL)
50732224109270(POUCH 7.5X13 SELFSEAL)

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