Primary Device ID | 07350096320340 |
NIH Device Record Key | 81f380c3-df6a-417e-98de-2801deab8ed2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Penguin II |
Version Model Number | Penguin II Instrument |
Catalog Number | 55241 |
Company DUNS | 352736781 |
Company Name | Integration Diagnostics Sweden AB |
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 | 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 | 07350096320333 [Primary] |
GS1 | 07350096320340 [Package] Contains: 07350096320333 Package: PenguinIISet Klockne [1 Units] In Commercial Distribution |
GS1 | 07350096320371 [Package] Contains: 07350096320333 Package: Penguin II Demo Set [1 Units] In Commercial Distribution |
GS1 | 07350096320456 [Package] Contains: 07350096320333 Package: IS4 Instrument Set [1 Units] In Commercial Distribution |
GS1 | 07350096320463 [Package] Contains: 07350096320333 Package: PenguinIISet Citagen [1 Units] In Commercial Distribution |
GS1 | 07350096320470 [Package] Contains: 07350096320333 Package: PenguinIISet Bredent [1 Units] In Commercial Distribution |
GS1 | 07350096320487 [Package] Contains: 07350096320333 Package: PenguinIISet NucleOS [1 Units] In Commercial Distribution |
GS1 | 07350096320494 [Package] Contains: 07350096320333 Package: PenguinIISet ABdenta [1 Units] In Commercial Distribution |
GS1 | 07350096320531 [Package] Contains: 07350096320333 Package: Penguin II Set SIC [1 Units] In Commercial Distribution |
EKX | Handpiece, Direct Drive, Ac-Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-28 |
Device Publish Date | 2023-12-20 |
07350096320272 - Osseo 100+ | 2024-11-07 |
07350096320425 - Penguin MDI | 2023-12-29 |
07350096320432 - MulTipeg™ | 2023-12-29 |
07350096320449 - Penguin MDI | 2023-12-29 |
07350096320340 - Penguin II | 2023-12-28 |
07350096320340 - Penguin II | 2023-12-28 |
07350096320043 - Penguin RFA | 2022-03-16 |
07350096320050 - Penguin RFA | 2022-03-16 |
07350096320067 - Penguin RFA | 2022-03-16 |