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Aligned Medical Solutions

FDA UDI

Class I (US FDA UDI)

by Aligned Medical Solutions

Identity

Trade Name
Aligned Medical Solutions FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
TOTAL HIP PACK FDA UDI
Model / Reference
AMS4021H FDA UDI
Description
TOTAL HIP PACK FDA UDI

Identifiers

Catalog Number
AMS4021H FDA UDI
Primary DI / UDI-DI
B098AMS4021H0 FDA UDI
FDA Product Code
OJH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

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: Orthopaedic surgical procedure kit, non-medicated, single-use

Aligned Medical Solutions by Aligned Medical Solutions — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic 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 4c442aec-cba4-4bbc-8502-c3e2d61ff21c 36 fields · synced May 31, 2026