| Primary Device ID | D661L5221 |
| NIH Device Record Key | 4fa2a560-7058-4359-9aff-9120c3160165 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TMS |
| Version Model Number | L522 |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | D661L5220 [Unit of Use] |
| HIBCC | D661L5221 [Primary] |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D661L5221]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2019-02-11 |
| 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 |