Identity
- Trade Name
- Plasdent FDA UDI
- Generic Name
- Medical equipment handle cover, single-use FDA UDI
- Device Name
- T-Shape Lite Handle Cover, 6"W X 3"L FDA UDI
- Model / Reference
- PS328T FDA UDI
- Description
- T-Shape Lite Handle Cover, 6"W X 3"L FDA UDI
Identifiers
- Catalog Number
- PS328T FDA UDI
- Primary DI / UDI-DI
- D832PS328T1 FDA UDI
- 510(k) Number
- K201604 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- Medical equipment handle cover, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical equipment handle cover, single-use
Plasdent by Plasdent Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201604 also covers:
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
- Plasdent — PLASDENT CORP.
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
- Plasdent Corp.
Sources (1)
- FDA UDI abb8058a-9a88-4f54-8979-7c7007c961bf 35 fields · synced Jun 8, 2026