TMS

GUDID D661L5221

MINIM Single Shear Bulk Kit

COLTENE/WHALEDENT INC

Dental restoration retention pin
Primary Device IDD661L5221
NIH Device Record Key4fa2a560-7058-4359-9aff-9120c3160165
Commercial Distribution StatusIn Commercial Distribution
Brand NameTMS
Version Model NumberL522
Company DUNS622185718
Company NameCOLTENE/WHALEDENT INC
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD661L5220 [Unit of Use]
HIBCCD661L5221 [Primary]

FDA Product Code

EBLPin, Retentive And Splinting, And Accessory Instruments

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D661L5221]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2019-02-11

On-Brand Devices [TMS]

D661T151REGULAR Self-Shearing Bulk Kit
D661T141REGULAR Self-Shearing Refill Kit
D661T131REGULAR Self-Shearing Complete Kit
D661T121MINIM 2-in-1 Bulk Kit
D661T1121MINUTA Refill Kit
D661T1111MINUTA Complete Kit
D661T111MINIM 2-in-1 Refill Kit
D661T1091MINIKIN Bulk Kit
D661T1081MINIKIN Refill Kit
D661T1071MINIKIN Complete Kit
D661T101MINIM 2-in-1 Complete Kit
D661T091REGULAR 2-in-1 Bulk Kit
D661T081REGULAR 2-in-1 Refill Kit
D661T071REGULAR 2-in-1 Complete Kit
D661T061MINIM Bulk Kit
D661T051MINIM Refill Kit
D661T041MINIM Complete Kit
D661T031REGULAR Bulk Kit
D661T021REGULAR Refill Kit
D661T011REGULAR Complete Kit
D661L8421MINIM Double Shear Bulk Kit - Titanium
D661L8411MINIM Double Shear Complete Kit - Titanium
D661L8221MINIM Single Shear Bulk Kit - Titanium
D661L8211MINIM Single Shear Complete Kit - Titanium
D661L8121MINIKIN Single Shear Bulk Kit - Titanium
D661L8111MINIKIN Single Shear Complete Kit - Titanium
D661L7521REGULAR Double Shear Bulk Kit
D661L7511REGULAR Double Shear Complete Kit
D661L7421REGULAR Single Shear Bulk Kit
D661L7411REGULAR Single Shear Complete Kit
D661L7321MINIM Double Shear Bulk Kit
D661L7311MINIM Double Shear Complete Kit
D661L7221MINIM Single Shear Bulk Kit
D661L7211MINIM Single Shear Complete Kit
D661L5521REGULAR Double Shear Bulk Kit
D661L5511REGULAR Double Shear Complete Kit
D661L5421REGULAR Single Shear Bulk Kit
D661L5411REGULAR Single Shear Complete Kit
D661L5321MINIM Double Shear Bulk Kit
D661L5311MINIM Double Shear Complete Kit
D661L5221MINIM Single Shear Bulk Kit
D661L5211MINIM Single Shear Complete Kit
D661L5121MINIKIN Single Shear Bulk Kit
D661L5111MINIKIN Single Shear Complete Kit
D661L5021MINUTA Single Shear Bulk Kit
D661L5011MINUTA Single Shear Complete Kit
D661B5950TMS MINIM and MINIM 2 in 1 Wrench
D661B5930TMS Regular and MINIKIN Wrench
D661B59100TMS MINUTA Wrench

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