MiniKut

GUDID 00850001745581

MiniKut Procedure Pack Large Canals (.15/.07, .25/.05, .35/.05) 25mm 3 Pack

DENTAL ENGINEERING LABORATORIES, LLC

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 00850001745581
• NIH Device Record Key: c86ce531-b23d-40ee-8705-1687ee66b057
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniKut
• Version Model Number: 1430525
• Company DUNS: 026444360
• Company Name: DENTAL ENGINEERING LABORATORIES, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com
• Phone: 805-963-2118
• Email: info@planbdental.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001745581 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

[00850001745581]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-23
• Device Publish Date: 2022-08-15

On-Brand Devices [MiniKut]

• 00850001745802: MiniKut MB2 Procedure Pack (15/.07, 15/.05 (mb2), 15/.03, 15/.05) 17mm & 25mm 4 Pack
• 00850001745772: MiniKut Retreatment Endodontic Files 25/.08, 25mm 3 Pack
• 00850001745765: MiniKut Retreatment Endodontic Files 25/.08, 21mm 3 Pack
• 00850001745758: MiniKut Retreatment Endodontic Files 20/.06, 25mm 3 Pack
• 00850001745741: MiniKut Retreatment Endodontic Files 20/.06, 21mm 3 Pack
• 00850001745734: MiniKut MB2 Rotary NiTi Endodontic Files 15/.05, 17mm 6 Pack
• 00850001745604: MiniKut EZ Rotary NiTi Endodontic Files .15/.03, 21mm 6 Pack
• 00850001745598: MiniKut Molar Sampler Pack (.15/.07, .15/.03, .20/.03, .25/.03, .25/.05, .35/.05) 25mm 6 Pack
• 00850001745581: MiniKut Procedure Pack Large Canals (.15/.07, .25/.05, .35/.05) 25mm 3 Pack
• 00850001745574: MiniKut Procedure Pack Small Canals (.15/.07, .15/.03, .25/.03) 25mm 3 Pack
• 00850001745567: MiniKut Orifice Opener Rotary NiTi Endodontic Files .15/.07, 17mm 6 Pack
• 00850001745550: MiniKut Rotary NiTi Endodontic Files .45/.05, 31mm 6 Pack
• 00850001745543: MiniKut Rotary NiTi Endodontic Files .45/.05, 25mm 6 Pack
• 00850001745536: MiniKut Rotary NiTi Endodontic Files .45/.05, 21mm 6 Pack
• 00850001745529: MiniKut Rotary NiTi Endodontic Files .40/.05, 31mm 6 Pack
• 00850001745512: MiniKut Rotary NiTi Endodontic Files .40/.05, 25mm 6 Pack
• 00850001745505: MiniKut Rotary NiTi Endodontic Files .40/.05, 21mm 6 Pack
• 00850001745499: MiniKut Rotary NiTi Endodontic Files .35/.05, 31mm 6 Pack
• 00850001745482: MiniKut Rotary NiTi Endodontic Files .35/.05, 25mm 6 Pack
• 00850001745475: MiniKut Rotary NiTi Endodontic Files .35/.05, 21mm 6 Pack
• 00850001745468: MiniKut Rotary NiTi Endodontic Files .30/.05, 31mm 6 Pack
• 00850001745451: MiniKut Rotary NiTi Endodontic Files .30/.05, 25mm 6 Pack
• 00850001745444: MiniKut Rotary NiTi Endodontic Files .30/.05, 21mm 6 Pack
• 00850001745437: MiniKut Rotary NiTi Endodontic Files .25/.05, 31mm 6 Pack
• 00850001745420: MiniKut Rotary NiTi Endodontic Files .25/.05, 25mm 6 Pack
• 00850001745413: MiniKut Rotary NiTi Endodontic Files .25/.05, 21mm 6 Pack
• 00850001745406: MiniKut Rotary NiTi Endodontic Files .20/.05, 31mm 6 Pack
• 00850001745390: MiniKut Rotary NiTi Endodontic Files .20/.05, 25mm 6 Pack
• 00850001745383: MiniKut Rotary NiTi Endodontic Files .20/.05, 21mm 6 Pack
• 00850001745376: MiniKut Rotary NiTi Endodontic Files .45/.03, 31mm 6 Pack
• 00850001745369: MiniKut Rotary NiTi Endodontic Files .45/.03, 25mm 6 Pack
• 00850001745352: MiniKut Rotary NiTi Endodontic Files .45/.03, 21mm 6 Pack
• 00850001745345: MiniKut Rotary NiTi Endodontic Files .40/.03, 31mm 6 Pack
• 00850001745338: MiniKut Rotary NiTi Endodontic Files .40/.03, 25mm 6 Pack
• 00850001745321: MiniKut Rotary NiTi Endodontic Files .40/.03, 21mm 6 Pack
• 00850001745314: MiniKut Rotary NiTi Endodontic Files .35/.03, 31mm 6 Pack
• 00850001745307: MiniKut Rotary NiTi Endodontic Files .35/.03, 25mm 6 Pack
• 00850001745291: MiniKut Rotary NiTi Endodontic Files .35/.03, 21mm 6 Pack
• 00850001745284: MiniKut Rotary NiTi Endodontic Files .30/.03 31mm 6 Pack
• 00850001745277: MiniKut Rotary NiTi Endodontic Files .30/.03, 25mm 6 Pack
• 00850001745260: MiniKut Rotary NiTi Endodontic Files .30/.03, 21mm 6 Pack
• 00850001745253: MiniKut Rotary NiTi Endodontic Files .25/.03, 31mm 6 Pack
• 00850001745246: MiniKut Rotary NiTi Endodontic Files .25/.03, 25mm 6 Pack
• 00850001745239: MiniKut Rotary NiTi Endodontic Files .25/.03, 21mm 6 Pack
• 00850001745222: MiniKut Rotary NiTi Endodontic Files .20/.03, 31mm 6 Pack
• 00850001745215: MiniKut Rotary NiTi Endodontic Files .20/.03, 25mm 6 Pack
• 00850001745208: MiniKut Rotary NiTi Endodontic Files .20/.03, 21mm 6 Pack
• 00850001745192: MiniKut EZP Rotary NiTi Endodontic Files .15/.05, 31mm 6 Pack
• 00850001745185: MiniKut EZP Rotary NiTi Endodontic Files .15/.05, 25mm 6 Pack
• 00850001745178: MiniKut EZP Rotary NiTi Endodontic Files .15/.05, 21mm 6 Pack