FDA UDI
In Commercial Distribution
🇺🇸 United States
Penguin II
DI: 07350096320333
·
Model: Penguin II Instrument
·
Integration Diagnostics Sweden AB
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
Basic Information
- Brand Name
- Penguin II
- Primary DI
- 07350096320333
- Version / Model
- Penguin II Instrument
- Catalog Number
- 55241
- Company Name
- Integration Diagnostics Sweden AB
- Labeler DUNS
- 352736781
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-20
- Public Version
- 1
- Public Version Date
- 2023-12-28
- Public Version Status
- New
- Public Device Record Key
- 81f380c3-df6a-417e-98de-2801deab8ed2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36576 | Multimeter | A battery-powered electronic instrument intended to be used to measure the amount or strength of values of an electric current, usually voltage and resistance. Sometimes, by means of additional probes, determinations such as sound level, or any form of energy that can be converted into an electrical signal, can be made. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07350096320340 | GS1 | PenguinIISet Klockne | 1 | In Commercial Distribution | |
| Primary | 07350096320333 | GS1 | ||||
| Package | 07350096320371 | GS1 | Penguin II Demo Set | 1 | In Commercial Distribution | |
| Package | 07350096320456 | GS1 | IS4 Instrument Set | 1 | In Commercial Distribution | |
| Package | 07350096320470 | GS1 | PenguinIISet Bredent | 1 | In Commercial Distribution | |
| Package | 07350096320463 | GS1 | PenguinIISet Citagen | 1 | In Commercial Distribution |