Primary Device ID | J015209492139 |
NIH Device Record Key | d6f16939-4a45-4d81-a898-7d1edd1555e0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ONE SHAPE APICAL |
Version Model Number | n037 6% L29 |
Catalog Number | 20949213 |
Company DUNS | 276075371 |
Company Name | MICRO MEGA |
Device Count | 5 |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Issuing Agency | Device ID |
---|---|
HIBCC | J015209492130 [Unit of Use] |
HIBCC | J015209492131 [Primary] |
HIBCC | J015209492139 [Package] Contains: J015209492131 Package: Box [10 Units] In Commercial Distribution |
EKS | File, Pulp Canal, Endodontic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-07 |
Device Publish Date | 2020-08-28 |
J015209492011 | Endodontic instrument for professionnal dental use only |
J015209492139 | Endodontic instrument for professionnal dental use only |
J015209492129 | Endodontic instrument for professionnal dental use only |
J015209492119 | Endodontic instrument for professionnal use only |
J015209492029 | Endodontic instrument for professionnal dental use only |