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Entopic Penile Implant and Sphincter Surgery Set

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
Entopic Penile Implant and Sphincter Surgery Set FDA UDI
Generic Name
General surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Entopic Penile Implant and Sphincter Surgery Set With Tray FDA UDI
Model / Reference
516-733-SET FDA UDI
Description
Entopic Penile Implant and Sphincter Surgery Set With Tray FDA UDI

Identifiers

Primary DI / UDI-DI
00192896110861 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, reusable 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

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

No

FDA UDI

Category: General surgical procedure kit, non-medicated, reusable

Entopic Penile Implant and Sphincter Surgery Set by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sontec Instruments, Inc.

Sources (1)

  • FDA UDI cc670ea6-9223-48dc-8da0-60d68f88a8f9 34 fields · synced Jun 8, 2026