Identity
- Trade Name
- PRINCETON FDA UDI
- Generic Name
- Pulmonary dilator FDA UDI
- Device Name
- DILATOR DEBAKEY VASCULAR MALLEABLE 4MM 7.5" FDA UDI
- Model / Reference
- 61810-40 FDA UDI
- Description
- DILATOR DEBAKEY VASCULAR MALLEABLE 4MM 7.5" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810158211339 FDA UDI
- FDA Product Code
- HDQ FDA UDI
- GMDN Term
- Pulmonary dilator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.4530 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Pulmonary dilator
Princeton by Princeton Medical Group, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary dilator.
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- ELMED — ELMED INCORPORATED · Class I
- HNM Medical — HNM STAINLESS, LLC. · Class II
- HNM Medical — HNM STAINLESS, LLC. · Class II
- ELMED — ELMED INCORPORATED · Class I
- ELMED — ELMED INCORPORATED · Class I
- HNM Medical — HNM STAINLESS, LLC. · 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
- Princeton Medical Group, Inc.
Sources (1)
- FDA UDI 7c736d46-53ef-4724-9eee-4769da4f848d 33 fields · synced May 29, 2026