FDA UDI
In Commercial Distribution
🇺🇸 United States
Sharn by Marketlab
DI: 00859290006489
·
Model: Sharn SSP-400
·
TRUER MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Sharn by Marketlab
- Primary DI
- 00859290006489
- Version / Model
- Sharn SSP-400
- Company Name
- TRUER MEDICAL, INC.
- Labeler DUNS
- 003530786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-29
- Public Version
- 1
- Public Version Date
- 2024-11-06
- Public Version Status
- New
- Public Device Record Key
- 37f686c5-fd8e-4f23-b969-f776060ec565
Device Description
The Sharn by Marketlab Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical procedures, postoperative recovery, or whenever a clinician needs to accurately assess patient skin temperature. The Sharn by Marketlab Skin Sensor has reflective silver material on one side to insulate the sensor from heat generated by operating room lights or heat lamps.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17888 | Infrared patient thermometer, skin | A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10859290006486 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00859290006489 | GS1 | ||||
| Package | 20859290006483 | GS1 | 26 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101244 | 000 |