Identity
- Trade Name
- GOMCO FDA UDI
- Generic Name
- General-purpose surgical suction system, vacuum FDA UDI
- Device Name
- ASPIRATOR, STAND MOUNTED, 115V/60HZ FDA UDI
- Model / Reference
- 01-62-3041 FDA UDI
- Description
- ASPIRATOR, STAND MOUNTED, 115V/60HZ FDA UDI
Identifiers
- Catalog Number
- 01-62-3041 FDA UDI
- Primary DI / UDI-DI
- 00026072002117 FDA UDI
- 510(k) Number
- K810490 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- General-purpose surgical suction system, vacuum FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose surgical suction system, vacuum
Gomco by Allied Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose surgical suction system, vacuum.
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- ADULT TIP SUCKER HEX HANDLE WITH VENT — NOVOSCI CORP. · Class II
- XinjingProWellness™ — Tianjin Newtrans Technology Development · Class II
- TIP SUCKER — NOVOSCI CORP. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
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Cleared under the same submission
K810490 also covers:
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
- GOMCO — Allied Medical LLC
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
- Allied Medical LLC
Sources (1)
- FDA UDI 39372970-845a-4036-bb9e-3da7ddd911da 35 fields · synced May 30, 2026