Identity
- Trade Name
- Plasdent FDA UDI
- Generic Name
- Surgical suction system collection container, reusable FDA UDI
- Device Name
- High Pressure Water Bottle, 750ml, 3 1/4"Dia. X 10"H FDA UDI
- Model / Reference
- HPB-4910 FDA UDI
- Description
- High Pressure Water Bottle, 750ml, 3 1/4"Dia. X 10"H FDA UDI
Identifiers
- Catalog Number
- HPB-4910 FDA UDI
- Primary DI / UDI-DI
- D832HPB49100 FDA UDI
- FDA Product Code
- NRD FDA UDI
- GMDN Term
- Surgical suction system collection container, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical suction system collection container, reusable
The Plasdent Corporation's High Pressure Water Bottle is a durable and effective surgical suction system collection container, designed for use in surgical settings. It features a sterile design, making it suitable for use prior to opening or during the use of an instrument, and has been labeled as not requiring Nuclear Regulatory League (NRL) approval.
Similar devices
Also classified as Surgical suction system collection container, reusable.
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- Allied Medical LLC — Allied Medical LLC · Class II
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- Large lid with conical patient connection 6–10 mm — Medela LLC · Class II
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- Allied Medical LLC — Allied Medical LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Plasdent Corp.
Sources (1)
- FDA UDI eb001ea5-c062-4e65-a9ec-d18d5a22f257 34 fields · synced Jul 18, 2026