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Stradis

FDA UDI

Class I (US FDA UDI)

by Stradis Medical, Llc

Identity

Trade Name
STRADIS FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
CUSTOM DENTAL KIT PROCEDURE PACK FDA UDI
Model / Reference
30061ABT FDA UDI
Description
CUSTOM DENTAL KIT PROCEDURE PACK FDA UDI

Identifiers

Primary DI / UDI-DI
M75230061ABT0 FDA UDI
FDA Product Code
OFX FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Category: General surgical procedure kit, non-medicated, single-use

Stradis by Stradis Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stradis Medical, Llc

Sources (1)

  • FDA UDI 32763ab8-046e-460a-8443-99f9da754a91 34 fields · synced Jun 6, 2026