| 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 |