Identity
- Trade Name
- AED-SLT KIT FDA UDI
- Generic Name
- Surgical power tool maintenance unit FDA UDI
- Device Name
- A complete set of AED-SLT hermetic seal testers for Midas Rex, Stryker, Dyonics, Conmed Linvatec and Arthrex medical power tools including a hand-held aneroid sphygmomanometer with pressure inflation bulb FDA UDI
- Model / Reference
- AED-SLT KIT FDA UDI
- Description
- A complete set of AED-SLT hermetic seal testers for Midas Rex, Stryker, Dyonics, Conmed Linvatec and Arthrex medical power tools including a hand-held aneroid sphygmomanometer with pressure inflation bulb FDA UDI
Identifiers
- Catalog Number
- AED-SLT KIT FDA UDI
- Primary DI / UDI-DI
- 00848657069441 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Surgical power tool maintenance unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical power tool maintenance unit
Aed-Slt Kit by National Advanced Endoscopy Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 8d2d8c84-59fb-4bfc-8c59-57c435a1b337 35 fields · synced May 30, 2026