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Croma

FDA UDI

Class II (US FDA UDI)

by Creo Medical, Ltd.

Identity

Trade Name
Croma FDA UDI
Generic Name
Endoscopic microwave ablation probe/needle FDA UDI
Device Name
HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following • Peptic Ulcers • Dieulafoy Lesions • Mallory-Weiss Tears • Bleeding Polyp Stalks • Arteriovenous Malformations (AVMs) • Angiomata The HS1 also has irrigation capability. Any other use is not recommended. FDA UDI
Model / Reference
Slypseal Flex FDA UDI
Description
HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following • Peptic Ulcers • Dieulafoy Lesions • Mallory-Weiss Tears • Bleeding Polyp Stalks • Arteriovenous Malformations (AVMs) • Angiomata The HS1 also has irrigation capability. Any other use is not recommended. FDA UDI

Identifiers

Catalog Number
7-HS1-001 FDA UDI
Primary DI / UDI-DI
05060359560223 FDA UDI
FDA Product Code
KNS FDA UDI
GMDN Term
Endoscopic microwave ablation probe/needle FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4300 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 1.8 Meter FDA UDI
Outer Diameter — 3.2 Millimeter FDA UDI

Category: Endoscopic microwave ablation probe/needle

Croma by Creo Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Creo Medical, Ltd.

Sources (1)

  • FDA UDI 87bddad4-ddb2-42fa-a4d7-78d2129c17d1 37 fields · synced Jun 8, 2026