Crosstex International UFVPML

GUDID 50732224000317

PROGUARDTM SODIUM FLOURIDE VARNISH - MELON

CROSSTEX INTERNATIONAL, INC.

Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish Dental cavity varnish

• Primary Device ID: 50732224000317
• NIH Device Record Key: 9501c8f7-55e4-4bb9-84cf-bb13a6a49ff4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crosstex International
• Version Model Number: UFVPML
• Catalog Number: UFVPML
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 50
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224000312 [Unit of Use]
GS1	10732224000319 [Primary]
GS1	50732224000317 [Package]; Contains: 10732224000319; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080814

FDA Product Code

• LBH: VARNISH, CAVITY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [Crosstex International]

• D682GPRN9525: Isolator Plus N95 Mask
• 50732224004162: Lead-Free Blue Indicator Steam Tape, 0.71 in X 60 yd (18 mm X 55 m) Roll
• 50732224004155: Lead-Free Blue Steam Indicator Tape, 0.94 in X 60 yd (24 mm X 55 m) Roll
• 50732224004148: Lead-Free Steam Indicator Tape, 0.47 in X 60 yd (12 mm X 55 m) Roll
• 50732224004131: Lead-Free Steam Indicator Tape, 0.71 in X 60 yd (18 mm X 55 m) Roll
• 50732224004124: Lead-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)
• 50732224109416: Crosstex Pouch 5.25X15
• 50732224109409: Crosstex 3.5X22 Sure Check
• 50732224109393: Crosstex Pouch 3.5X22
• 50732224109386: (SURE-CHECK 7.50" x 13", 200/BX - 5/CS)
• 50732224109362: Sure-Check 12" x 18", 100/BX - 5/CS
• 50732224109355: Pouch 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)