FDA UDI
In Commercial Distribution
🇺🇸 United States
beyond scrubs®
DI: 00634782058746
·
Model: 395SBQ
·
AMERICAN DIAGNOSTIC CORP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- beyond scrubs®
- Primary DI
- 00634782058746
- Version / Model
- 395SBQ
- Catalog Number
- 395SBQ
- Company Name
- AMERICAN DIAGNOSTIC CORP
- Labeler DUNS
- 108999095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-07
- Public Version
- 4
- Public Version Date
- 2024-07-25
- Public Version Status
- Update
- Public Device Record Key
- a82d6e71-6312-4de7-8ea0-c0e70bd19df5
Device Description
EKG Caliper,Pewter, SB PL, Disp pkg
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 |
|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37743 | Tape measure, reusable | A flexible, manual, non-electronic device intended to be used in a clinical setting to establish an accurate measurement of length greater than a standard ruler (e.g., the circumference of a patient's waist or thigh, or length of a leg). It is typically made of oilcloth or pliable steel and marked in units of length (i.e., inches and/or millimetres). It is usually available as a roll which may be encased in a holder. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00634782558550 | GS1 | Master Case | 4 | In Commercial Distribution | |
| Package | 00634782858551 | GS1 | Inner pack | 12 | In Commercial Distribution | |
| Primary | 00634782058746 | GS1 |
Customer Contacts
- Phone
- 1-800-232-2670
- [email protected]