EnsoETM ECD01-A
by Advanced Cooling Therapy, LLC 2 variants
EnsoETM ECD01-A is a Class II device made by Advanced Cooling Therapy, LLC, listed in FDA GUDID since 17 May 2018 (UDI-DI 00857915006166), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00857915006166 | Date17 May 2018 | StatusListed |
Official records
- AccessGUDID record 00857915006166
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- EnsoETM
- Generic name
- Endoscopic bite block, basic, single-use
- Model / reference
- ECD01-A
- Primary DI / UDI-DI
- 00857915006166
- FDA product code
- PLA, KMJ, JAY, QXV
- GMDN term
- Endoscopic bite block, basic, single-use
- Device class
- Class II
- Regulation number
- 870.5910, 880.6375, 868.5280, 870.5720
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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