Primary Device ID | D948PBXM2N250 |
NIH Device Record Key | 69d4e51d-3213-456e-b2f9-10dadec371cd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Paradigm BX |
Version Model Number | M2 |
Catalog Number | PBX-M2-N25 |
Company DUNS | 200106716 |
Company Name | Smarter Alloys Inc |
Device Count | 6 |
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 | false |
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 | D948PBXM2N250 [Unit of Use] |
HIBCC | D948PBXM2N251 [Primary] |
EKS | File, Pulp Canal, Endodontic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D948PBXM2N250]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-29 |
Device Publish Date | 2020-05-21 |
D948PBXM5N250 | Multi-taper NiTi rotary endodontic file, size M5, 25mm length |
D948PBXM4N250 | Multi-taper NiTi rotary endodontic file, size M4, 25mm length |
D948PBXM3N250 | Multi-taper NiTi rotary endodontic file, size M3, 25mm length |
D948PBXM2N250 | Multi-taper NiTi rotary endodontic file, size M2, 25mm length |
D948PBXM1N250 | Multi-taper NiTi rotary endodontic file, size M1, 25mm length |
D948PBXAXN190 | Multi-taper NiTi rotary endodontic file, size AX, 19mm length |
D948PBXASN250 | Multi-taper NiTi rotary endodontic file, assorted pack, sizes AX-M3, 19-25mm length |
D948PBXA2N250 | Multi-taper NiTi rotary endodontic file, size A2, 25mm length |
D948PBXA1N250 | Multi-taper NiTi rotary endodontic file, size A1, 25mm length |