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Elmed

FDA UDI

Class I (US FDA UDI)

by Elmed Incorporated

Identity

Trade Name
ELMED FDA UDI
Generic Name
Robotic surgical system application software FDA UDI
Device Name
CYSTO GRID MARKER STAINLESS STEEL FDA UDI
Model / Reference
83-31000-CC FDA UDI
Description
CYSTO GRID MARKER STAINLESS STEEL FDA UDI

Identifiers

Catalog Number
83-31000-CC FDA UDI
Primary DI / UDI-DI
00198506058103 FDA UDI
FDA Product Code
KOA FDA UDI
GMDN Term
Robotic surgical system application software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Robotic surgical system application software

Elmed by Elmed Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elmed Incorporated

Sources (1)

  • FDA UDI 578aa877-9dbb-4348-9d98-2bcf16e0dbd4 35 fields · synced Jun 6, 2026