Identity
- Trade Name
- Skin Probe, Large FDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Device Name
- Reusable temperature probe, Skin application, large FDA UDI
- Model / Reference
- SAR-275PRA FDA UDI
- Description
- Reusable temperature probe, Skin application, large FDA UDI
Identifiers
- Catalog Number
- 011-00122 FDA UDI
- Primary DI / UDI-DI
- 04260651380227 FDA UDI
- 510(k) Number
- K203643 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- General-purpose patient temperature probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 2.8 Meter FDA UDI
Category: General-purpose patient temperature probe, reusable
Skin Probe, Large by Sensatronic GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose patient temperature probe, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
Cleared under the same submission
K203643 also covers:
- General Purpose Rectal/Esophageal Probe, Large — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Large — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Large, Schiller — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Large, Schiller — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Large, Schiller — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Medium — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Medium — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Medium, Schiller — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Medium, Schiller — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Medium, Schiller — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Small — Sensatronic GmbH
- General Purpose Rectal/Esophageal Probe, Small — Sensatronic GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sensatronic GmbH
Sources (1)
- FDA UDI c572cc25-d246-434a-b67a-902de450b7f2 37 fields · synced May 30, 2026