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Advantis Medical / SteriPack

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Advantis Medical / SteriPack FDA UDI
Generic Name
Device sterilization/disinfection container, reusable FDA UDI
Device Name
Microsurgical aluminum instrument sterilization tray, 10 1/2'' W x 15'' L x 2 1/2'' H, double level, silicone finger strips, includes full height accessory area FDA UDI
Model / Reference
Microsurgical aluminum instrument sterilization tray FDA UDI
Description
Microsurgical aluminum instrument sterilization tray, 10 1/2'' W x 15'' L x 2 1/2'' H, double level, silicone finger strips, includes full height accessory area FDA UDI

Identifiers

Catalog Number
93-879 FDA UDI
Primary DI / UDI-DI
00190660188917 FDA UDI
FDA Product Code
LRP FDA UDI
GMDN Term
Device sterilization/disinfection container, 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Device sterilization/disinfection container, reusable

Advantis Medical / SteriPack by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Device sterilization/disinfection container, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 4a2a8d43-9c2b-499d-8b75-83baee550ff2 35 fields · synced May 31, 2026