TMS

GUDID D661T151

REGULAR Self-Shearing Bulk Kit

COLTENE/WHALEDENT INC

Dental restoration retention pin

• Primary Device ID: D661T151
• NIH Device Record Key: 5934f564-551c-41d8-8975-e7ebfd066c95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMS
• Version Model Number: T15
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• Device Count: 100
• 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: false
• 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
HIBCC	D661T150 [Unit of Use]
HIBCC	D661T151 [Primary]

FDA Product Code

• EBL: Pin, Retentive And Splinting, And Accessory Instruments

Sterilization

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

[D661T151]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-02-26

On-Brand Devices [TMS]

• D661T151: REGULAR Self-Shearing Bulk Kit
• D661T141: REGULAR Self-Shearing Refill Kit
• D661T131: REGULAR Self-Shearing Complete Kit
• D661T121: MINIM 2-in-1 Bulk Kit
• D661T1121: MINUTA Refill Kit
• D661T1111: MINUTA Complete Kit
• D661T111: MINIM 2-in-1 Refill Kit
• D661T1091: MINIKIN Bulk Kit
• D661T1081: MINIKIN Refill Kit
• D661T1071: MINIKIN Complete Kit
• D661T101: MINIM 2-in-1 Complete Kit
• D661T091: REGULAR 2-in-1 Bulk Kit
• D661T081: REGULAR 2-in-1 Refill Kit
• D661T071: REGULAR 2-in-1 Complete Kit
• D661T061: MINIM Bulk Kit
• D661T051: MINIM Refill Kit
• D661T041: MINIM Complete Kit
• D661T031: REGULAR Bulk Kit
• D661T021: REGULAR Refill Kit
• D661T011: REGULAR Complete Kit
• D661L8421: MINIM Double Shear Bulk Kit - Titanium
• D661L8411: MINIM Double Shear Complete Kit - Titanium
• D661L8221: MINIM Single Shear Bulk Kit - Titanium
• D661L8211: MINIM Single Shear Complete Kit - Titanium
• D661L8121: MINIKIN Single Shear Bulk Kit - Titanium
• D661L8111: MINIKIN Single Shear Complete Kit - Titanium
• D661L7521: REGULAR Double Shear Bulk Kit
• D661L7511: REGULAR Double Shear Complete Kit
• D661L7421: REGULAR Single Shear Bulk Kit
• D661L7411: REGULAR Single Shear Complete Kit
• D661L7321: MINIM Double Shear Bulk Kit
• D661L7311: MINIM Double Shear Complete Kit
• D661L7221: MINIM Single Shear Bulk Kit
• D661L7211: MINIM Single Shear Complete Kit
• D661L5521: REGULAR Double Shear Bulk Kit
• D661L5511: REGULAR Double Shear Complete Kit
• D661L5421: REGULAR Single Shear Bulk Kit
• D661L5411: REGULAR Single Shear Complete Kit
• D661L5321: MINIM Double Shear Bulk Kit
• D661L5311: MINIM Double Shear Complete Kit
• D661L5221: MINIM Single Shear Bulk Kit
• D661L5211: MINIM Single Shear Complete Kit
• D661L5121: MINIKIN Single Shear Bulk Kit
• D661L5111: MINIKIN Single Shear Complete Kit
• D661L5021: MINUTA Single Shear Bulk Kit
• D661L5011: MINUTA Single Shear Complete Kit
• D661B5950: TMS MINIM and MINIM 2 in 1 Wrench
• D661B5930: TMS Regular and MINIKIN Wrench
• D661B59100: TMS MINUTA Wrench