← Back to catalogue

Aadco

FDA UDI

Class I (US FDA UDI)

by Aadco Medical, Inc.

Identity

Trade Name
AADCO FDA UDI
Generic Name
Sterilization packaging, single-use FDA UDI
Device Name
STERILE DOME BAG 30" FDA UDI
Model / Reference
DB-0030E FDA UDI
Description
STERILE DOME BAG 30" FDA UDI

Identifiers

Catalog Number
DB-0030E FDA UDI
Primary DI / UDI-DI
00840348525670 FDA UDI
FDA Product Code
IWQ FDA UDI
GMDN Term
Sterilization packaging, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.6500 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

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sterilization packaging, single-use

Aadco by Aadco Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sterilization packaging, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aadco Medical, Inc.

Sources (1)

  • FDA UDI f843cc98-fa3f-445c-b656-ad87d9683289 34 fields · synced May 30, 2026