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Stradis Medical, LLC.

FDA UDI

Class I (US FDA UDI)

by Stradis Medical, Llc

Identity

Trade Name
Stradis Medical, LLC. FDA UDI
Generic Name
Submucosal injection needle FDA UDI
Model / Reference
525-057 FDA UDI

Identifiers

Primary DI / UDI-DI
M7525250570 FDA UDI
FDA Product Code
GAA FDA UDI
GMDN Term
Submucosal injection needle 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

Yes

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

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

No

FDA UDI

Category: Submucosal injection needle

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

Similar devices

Also classified as Submucosal injection needle.

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 d60f4088-417b-4379-8d70-3f159c1c5b52 33 fields · synced Jun 8, 2026