Identity
- Trade Name
- Avaline Medical NJ LLC FDA UDI
- Generic Name
- Urine strainer FDA UDI
- Device Name
- Calculi Strainer / Kidney Stone Collector (2 Pack) FDA UDI
- Model / Reference
- VKKSC02 FDA UDI
- Description
- Calculi Strainer / Kidney Stone Collector (2 Pack) FDA UDI
Identifiers
- Catalog Number
- VKKSC02 FDA UDI
- Primary DI / UDI-DI
- 00810077211656 FDA UDI
- FDA Product Code
- FNP FDA UDI
- GMDN Term
- Urine strainer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6730 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine strainer
Avaline Medical NJ LLC by Avaline Medical NJ Limited Liability Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine strainer.
- Therapak — Therapak LLC · Class I
- Medegen Medical Products, LLC — Medegen Medical Products · Class II
- Therapak — Therapak LLC · Class I
- BUSSE HOSPITAL DISPOSABLES — ROBERT BUSSE & CO., INC. · Class I
- Therapak — Therapak LLC · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Dover — Cardinal Health 200, LLC · Class I
- Therapak — Therapak LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avaline Medical NJ Limited Liability Company
Sources (1)
- FDA UDI ff777fb5-9371-43e0-8670-253a42a67370 35 fields · synced May 31, 2026