Identity
- Trade Name
- EndoClot Applicator FDA UDI
- Generic Name
- Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use FDA UDI
- Model / Reference
- EA230 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16972011720110 FDA UDI
- 510(k) Number
- K162197 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use
EndoClot Applicator by EndoClot Plus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use.
- Spine Needle (18 Gauge) — ELLIQUENCE LLC · Class II
- ETHICON — Ethicon Inc. · Class II
- ETHICON — Ethicon Inc. · Class II
- PDO Max Cannula — Max Pdo Inc · Class I
- PDO Max Cannulas — Max Pdo Inc · Class I
- PDO Max Cannulas — Max Pdo Inc · Class I
- PDO Max Cannula — Max Pdo Inc · Class I
- Reprocessed Universal Cannula Set Without Fenestration — SURETEK MEDICAL · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EndoClot Plus, Inc.
Sources (1)
- FDA UDI f3258f82-9a8a-4878-918f-df68728bde74 33 fields · synced May 30, 2026