Identity
- Trade Name
- Temple Arm Cover FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- Temple Arm Cover FDA UDI
- Model / Reference
- Temple Arm Cover FDA UDI
- Description
- Temple Arm Cover FDA UDI
Identifiers
- Catalog Number
- 152-10014 FDA UDI
- Primary DI / UDI-DI
- 00814005024813 FDA UDI
- FDA Product Code
- HJH FDA UDI
- GMDN Term
- Surgical binoculars, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5120 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Surgical binoculars, reusable
Temple Arm Cover by Quality Aspirators, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical binoculars, reusable.
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- SuperVu XL Advantage 3.5x, at 34cm working distanc — Rudolf Riester GmbH & Co. KG · Class I
- Surgical Telescope — Xenosys Co., Ltd. · Class I
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
- Quality Aspirators, Inc.
Sources (1)
- FDA UDI cb760bf1-7c30-4896-8753-2d04e3ab922c 34 fields · synced Jun 8, 2026