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Custom Healthcare Systems, Inc

FDA UDI

Class I (US FDA UDI)

by Manus Medical, LLC

Identity

Trade Name
CUSTOM HEALTHCARE SYSTEMS, INC FDA UDI
Generic Name
Suture kit, non-medicated FDA UDI
Model / Reference
SJ-19319 FDA UDI

Identifiers

Primary DI / UDI-DI
00811870034176 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Suture kit, non-medicated 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: Suture kit, non-medicated

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

Similar devices

Also classified as Suture kit, non-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 001aa5b9-9a0e-4979-bbf8-31f3f4afda25 32 fields · synced May 30, 2026