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Manus Medical, LLC

FDA UDI

Class I (US FDA UDI)

by Manus Medical, LLC

Identity

Trade Name
Manus Medical, LLC FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
TAA EFFICIENCY KIT FDA UDI
Model / Reference
LPGM-001 FDA UDI
Description
TAA EFFICIENCY KIT FDA UDI

Identifiers

Primary DI / UDI-DI
00811870037887 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

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

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

Manus Medical, LLC by Manus Medical, LLC — 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
Manus Medical, LLC

Sources (1)

  • FDA UDI d00e33e2-7d3a-49cc-a4b3-2e29dcee3c12 33 fields · synced May 30, 2026