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Aligned Medical Solutions

FDA UDI

Class II (US FDA UDI)

by Aligned Medical Solutions

Identity

Trade Name
Aligned Medical Solutions FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
ANESTHESIA KIT - NS FDA UDI
Model / Reference
AMS12578B FDA UDI
Description
ANESTHESIA KIT - NS FDA UDI

Identifiers

Catalog Number
AMS12578B FDA UDI
Primary DI / UDI-DI
B098AMS1257B0 FDA UDI
FDA Product Code
LRO FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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

Yes

FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

Aligned Medical Solutions General Surgery Tray openfda tray is a single-use, non-medicated anesthesia kit designed for general surgical procedures. This device is not sterile, has no lot or batch number, and does not contain pharmaceuticals.

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aligned Medical Solutions

Sources (1)

  • FDA UDI 61a412f1-b946-495f-8fbd-19901630f2c9 36 fields · synced Jul 7, 2026