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Disposable Sclerotherapy Needle

FDA UDI

Class II (US FDA UDI)

by TeleMed Systems

Identity

Trade Name
Disposable Sclerotherapy Needle FDA UDI
Generic Name
Sclerotherapy endoscopic needle, single-use FDA UDI
Device Name
Sure-Stop Sclerotherapy Needle 25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 240cm Working Length FDA UDI
Model / Reference
2015 FDA UDI
Description
Sure-Stop Sclerotherapy Needle 25GA Needle Diameter x 2.3mm Sheath Diameter x 5mm Needle Length x 240cm Working Length FDA UDI

Identifiers

Primary DI / UDI-DI
00813353010257 FDA UDI
510(k) Number
K901437 FDA UDI
FDA Product Code
FBK FDA UDI
GMDN Term
Sclerotherapy endoscopic needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Sclerotherapy endoscopic needle, single-use

Disposable Sclerotherapy Needle by TeleMed Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sclerotherapy endoscopic needle, single-use.

Cleared under the same submission

K901437 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
TeleMed Systems

Sources (1)

  • FDA UDI 8ad624f5-c190-48ab-b218-5373ea7bbbb9 34 fields · synced May 30, 2026