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Custom Healthcare Systems, Inc

FDA UDI

Class II (US FDA UDI)

by Manus Medical, LLC

Identity

Trade Name
CUSTOM HEALTHCARE SYSTEMS, INC FDA UDI
Generic Name
Myelography kit FDA UDI
Model / Reference
B9-15064 FDA UDI

Identifiers

Primary DI / UDI-DI
00811870034305 FDA UDI
FDA Product Code
OGJ FDA UDI
GMDN Term
Myelography kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5140 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: Myelography kit

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

Similar devices

Also classified as Myelography kit.

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 df35d0e7-872d-4168-b8fe-1f22f865181d 32 fields · synced Jun 8, 2026