Identity
- Trade Name
- Microscope Cover LEICA 115/260 M84 FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Medical equipment drape, single-use FDA UDI
- Model / Reference
- 8841 FDA UDI
- Description
- Medical equipment drape, single-use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00836230000615 FDA UDI
- FDA Product Code
- HRM FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical equipment/instrument drape, single-use
Microscope Cover LEICA 115/260 M84 by Pharma Sept Medical Products (1995) Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medical equipment/instrument drape, single-use.
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- MICROTEK — Microtek Medical LLC · Class II
- Plasdent — PLASDENT CORP. · Class II
- Probe Cover — Advance Medical Designs, Inc. · Class II
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
- Pharma Sept Medical Products (1995) Ltd.
Sources (1)
- FDA UDI 58bf6f36-8119-41ce-8d52-5ec737b284cd 33 fields · synced May 30, 2026