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Manus Medical, LLC

FDA UDI

Class II (US FDA UDI)

by Manus Medical, LLC

Identity

Trade Name
Manus Medical, LLC FDA UDI
Generic Name
General surgical procedure kit, medicated FDA UDI
Device Name
Combo Tray 1 & 2 FDA UDI
Model / Reference
COMBO-17891-1 FDA UDI
Description
Combo Tray 1 & 2 FDA UDI

Identifiers

Primary DI / UDI-DI
00811870037894 FDA UDI
FDA Product Code
LRO FDA UDI
GMDN Term
General surgical procedure kit, medicated 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

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

No

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: General surgical procedure kit, medicated

Manus Medical, LLC by Manus Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, medicated.

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 875be370-ddd7-41b0-af62-2be53c1045fc 33 fields · synced Jun 1, 2026