FDA UDI
In Commercial Distribution
🇺🇸 United States
Proscope™
DI: 00634782006402
·
Model: 670NP
·
AMERICAN DIAGNOSTIC CORP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Proscope™
- Primary DI
- 00634782006402
- Version / Model
- 670NP
- Catalog Number
- 670NP
- Company Name
- AMERICAN DIAGNOSTIC CORP
- Labeler DUNS
- 108999095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 10e9f397-d13d-40f0-9176-b932f25d473d
Device Description
PROSCOPE Dualhead Scope,32.25", Neon Pink
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LDE | Stethoscope, Manual | Cardiovascular | 870.1875 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13755 | Mechanical stethoscope | A mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00634782506391 | GS1 | Master Case | 50 | In Commercial Distribution | |
| Primary | 00634782006402 | GS1 |
Customer Contacts
- Phone
- 1-800-232-2670
- [email protected]