Primary Device ID | D90980014818 |
NIH Device Record Key | e9bfdeb3-440e-4689-9453-87593bed6d7d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ECLIPSE SLB CLOSING TOOL |
Version Model Number | 800-148 |
Catalog Number | 800-148 |
Company DUNS | 020956330 |
Company Name | Ortho Arch Company Inc |
Device Count | 1 |
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 | D90980014818 [Primary] |
JEX | Plier, Orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-06 |
Device Publish Date | 2023-06-28 |
D9098001290 - SPECTRUM | 2023-07-06 SPECTRUM LINGUAL ARCH FORMING PLIER |
D9098001302 - SPECTRUM | 2023-07-06 SPECTRUM TORQUING PLIER SET W/ WIDE KEY |
D9098001311 - SPECTRUM | 2023-07-06 SPECTRUM WIDE REPLACEMENT KEY |
D9098001321 - SPECTRUM | 2023-07-06 SPECTRUM THREE PRONG FACEMASK/ FACEBOW PLIER |
D90980014111 - MOLAR OPENING TOOL | 2023-07-06 SLB MOLAR OPENING TOOL |
D90980014616 - OPENING TOOL | 2023-07-06 ECLIPSE SLB OPENING TOOL |
D90980014717 - CLOSING TOOL | 2023-07-06 ECLIPSE SLB CLOSING TOOL |
D90980014818 - ECLIPSE SLB CLOSING TOOL | 2023-07-06ECLIPSE SLB CLOSING TOOL W/ WIRE DIRECTOR |
D90980014818 - ECLIPSE SLB CLOSING TOOL | 2023-07-06 ECLIPSE SLB CLOSING TOOL W/ WIRE DIRECTOR |