Primary Device ID | 00190730088796 |
NIH Device Record Key | 8471a402-d61f-4743-8186-2461a63a3648 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Extraoral Cheek Retractors |
Version Model Number | ORT-300-022 |
Company DUNS | 781772017 |
Company Name | ORTHO TECHNOLOGY, INC. |
Device Count | 1 |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
---|---|
GS1 | 00190730088796 [Primary] |
EIG | RETRACTOR, ALL TYPES |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-24 |
Device Publish Date | 2021-09-16 |
00190730033017 | Retractor Extraoral HH Adult Heat Sterilizable up to 370° |
00190730033000 | Retractor Extraoral HH Pedo Heat Sterilizable up to 370° |
00190730032997 | Retractor Extraoral Aclv Adult Autoclavable up to 270° |
00190730032980 | Retractor Extraoral Aclv Pedo Autoclavable up to 270° |
00190730032973 | *Retractor Extraoral Disp Adult 10 per pack, Disposable |
00190730088796 | Cheek Retractor Extraoral Teen 2/pk |
00190730088789 | Cheek Retractor Extraoral Pedo 2/pk |
00190730088772 | Cheek Retractor Extraoral Adult 2/pk |