Primary Device ID | 04961333248117 |
NIH Device Record Key | c39e1010-d1a2-45c4-b545-cf187a081f8a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pentax of America |
Version Model Number | 9380 |
Company DUNS | 083211284 |
Company Name | PENTAX OF AMERICA, 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 | true |
Single Use | false |
Lot Batch | false |
Serial Number | true |
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 | 04961333248117 [Primary] |
OUG | Medical Device Data System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-11-14 |
Device Publish Date | 2022-11-04 |
04961333255313 - C2 CryoBalloon | 2024-09-20 |
04961333255320 - C2 CryoBalloon | 2024-09-20 |
04961333254309 - MULTI-SPEECH | 2023-09-04 Multi-Speech Microphone, Condensor |
04961333248117 - Pentax of America | 2022-11-14Capture Module |
04961333248117 - Pentax of America | 2022-11-14 Capture Module |
04961333248445 - C2 CryoBalloon Nitroclip | 2020-08-17 NitroClip |
00854924006408 - C2 CryoBalloon EndoGrip | 2020-08-06 EndoGrip |
04961333248001 - ENDOPRO REVIEW WORKSTATION | 2020-04-03 ENDOPRO REVIEW WORKSTATION |
04961333248018 - ENDOPRO NETWORK CAPTURE WORKSTATION | 2020-04-03 ENDOPRO CAPTURE WORKSTATION, NETWORK |