Identity
- Trade Name
- Quickloop Abscess Treatment Device FDA UDI
- Generic Name
- Wound irrigation cannula FDA UDI
- Device Name
- Device for draining and irrigating cutaneous and oral fluid collections such as abscesses, seromas and hematomas. FDA UDI
- Model / Reference
- M01-0-0005 FDA UDI
- Description
- Device for draining and irrigating cutaneous and oral fluid collections such as abscesses, seromas and hematomas. FDA UDI
Identifiers
- Catalog Number
- M01-0-0005 FDA UDI
- Primary DI / UDI-DI
- B762M01000010 FDA UDI
- FDA Product Code
- GBX FDA UDI
- GMDN Term
- Wound irrigation cannula FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound irrigation cannula
Quickloop Abscess Treatment Device by Em Device Lab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Wound irrigation cannula.
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- Sterile Disposable Button Cannula, 100 mm length — Pemax Kunststoff GmbH · Class I
- SALINE LOCK KIT — SAFEGUARD US OPERATING, LLC · Class II
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- 80-110-10 Saline Lock Kit Case of 10 — SAFEGUARD US OPERATING, 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
- Em Device Lab, Inc.
Sources (1)
- FDA UDI 97575564-457e-4d18-8c1b-93ed9eab1b9a 35 fields · synced Jun 8, 2026