TENAX Fiber Trans

GUDID D661600226590

TENAX Fiber Trans Size 1.1

COLTENE/WHALEDENT INC

Root canal post, preformed

• Primary Device ID: D661600226590
• NIH Device Record Key: 58d9e6c4-f2bc-420f-abc8-67f16a9f0645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TENAX Fiber Trans
• Version Model Number: 60022659
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840016202001 [Secondary]
HIBCC	D661600226590 [Unit of Use]
HIBCC	D661600226591 [Primary]

FDA Product Code

• ELR: Post, Root Canal

Sterilization

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

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

[D661600226590]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-06
• Device Publish Date: 2024-11-28

On-Brand Devices [TENAX Fiber Trans]

• D661TFT15C0: TENAX FIBER TRANS 1.5 REFILL
• D661TFT13C0: TENAX FIBER TRANS 1.3 REFILL
• D661TFT11C0: TENAX FIBER TRANS 1.1 REFILL
• D661TFT150: TENAX Fiber Trans Size 1.5
• D661TFT130: TENAX Fiber Trans Size 1.3
• D661TFT11B0: TENAX Fiber Trans Size 1.1
• D661TFT110: TENAX Fiber Trans Size 1.1
• D661TFT10: TENAX Fiber Trans One-Office-Visit Technique
• D661600226610: TENAX Fiber Trans Size 1.5
• D6616002266010: TENAX Fiber Trans Size 1.3
• D661600226590: TENAX Fiber Trans Size 1.1
• D661600199100: TENAX Fiber Trans Training Kit
• D661600185760: Tenax Fiber Trans Size 1.5
• D6616001857510: Tenax Fiber Trans Size 1.3
• D661600185740: Tenax Fiber Trans Size 1.1