Sure-endo

GUDID 08809264299432

Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #00, 100 in (254cm)

SURE DENT CORPORATION

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• Primary Device ID: 08809264299432
• NIH Device Record Key: b3b818ab-d831-4d3e-9984-c9b39ebe090a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure-endo
• Version Model Number: SCP-00
• Company DUNS: 688273010
• Company Name: SURE DENT CORPORATION
• Device Count: 1
• DM Exempt: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809264299432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132526

FDA Product Code

• MVL: Cord, Retraction

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: 2023-11-14
• Device Publish Date: 2023-11-06

On-Brand Devices [Sure-endo]

• 08809264299982: Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #2, 100 in (254cm
• 08809264299975: Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #1, 100 in (254cm
• 08809264299968: Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #0, 100 in (254cm
• 08809264299951: Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #00, 100 in (254c
• 08809264299944: Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #000, 100 in (254
• 08809264299883: Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #000.0, 100 in (2
• 88809264299834: Gutta Percha Obturator, Size Soft, 100ea/box
• 88809264299827: Gutta Percha Obturator, Size Regular, 100ea/box
• 88809264299810: Gutta Percha Obturator, Size Hard, 100ea/box
• 08809264299098: Sure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #3, 100 in (254cm)
• 08809264299081: Sure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #2, 100 in (254cm)
• 08809264299074: Sure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #1, 100 in (254cm)
• 08809264299067: Sure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #0, 100 in (254cm)
• 08809264299050: Sure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #00, 100 in (254cm)
• 08809264299043: Sure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #000, 100 in (254cm)
• 08809264294550: Absorbent Paper Points, Size F5, 100/PK
• 08809264294543: Absorbent Paper Points, Size F4F5, 100/PK
• 08809264294536: Absorbent Paper Points, Size F4, 100/PK
• 08809264294529: Absorbent Paper Points, Size F3, 100/PK
• 08809264294512: Absorbent Paper Points, Size F2, 100/PK
• 08809264294505: Absorbent Paper Points, Size F1F2F3, 100/PK
• 08809264294499: Absorbent Paper Points, Size F1, 100/PK
• 08809264294482: Absorbent Paper Points Taper .06, Size 80, 100/PK
• 08809264294475: Absorbent Paper Points Taper .06, Size 70, 100/PK
• 08809264294468: Absorbent Paper Points Taper .06, Size 60, 100/PK
• 08809264294451: Absorbent Paper Points Taper .06, Size 55, 100/PK
• 08809264294444: Absorbent Paper Points Taper .06, Size 50, 100/PK
• 08809264294437: Absorbent Paper Points Taper .06, Size 45, 100/PK
• 08809264294420: Absorbent Paper Points Taper .06, Size 40, 100/PK
• 08809264294413: Absorbent Paper Points Taper .06, Size 35, 100/PK
• 08809264294406: Absorbent Paper Points Taper .06, Size 30, 100/PK
• 08809264294390: Absorbent Paper Points Taper .06, Size 25, 100/PK
• 08809264294383: Absorbent Paper Points Taper .06, Size 20-45, 100/PK
• 08809264294376: Absorbent Paper Points Taper .06, Size 20, 100/PK
• 08809264294369: Absorbent Paper Points Taper .06, Size 15, 100/PK
• 08809264294352: Absorbent Paper Points Taper .04, Size 80, 100/PK
• 08809264294345: Absorbent Paper Points Taper .04, Size 70, 100/PK
• 08809264294338: Absorbent Paper Points Taper .04, Size 60, 100/PK
• 08809264294321: Absorbent Paper Points Taper .04, Size 55, 100/PK
• 08809264294314: Absorbent Paper Points Taper .04, Size 50, 100/PK
• 08809264294307: Absorbent Paper Points Taper .04, Size 45, 100/PK
• 08809264294291: Absorbent Paper Points Taper .04, Size 40, 100/PK
• 08809264294284: Absorbent Paper Points Taper .04, Size 35, 100/PK
• 08809264294277: Absorbent Paper Points Taper .04, Size 30, 100/PK
• 08809264294260: Absorbent Paper Points Taper .04, Size 25, 100/PK
• 08809264294253: Absorbent Paper Points Taper .04, Size 20-45, 100/PK
• 08809264294246: Absorbent Paper Points Taper .04, Size 20, 100/PK
• 08809264294239: Absorbent Paper Points Taper .04, Size 15, 100/PK
• 08809264294222: Absorbent Paper Points Taper .02, Size 90-140, 200/PK
• 08809264294215: Absorbent Paper Points Taper .02, Size 140, 200/PK