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Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc

Identity

Trade Name
Epimed FDA UDI
Generic Name
Cryogenic analgesia unit FDA UDI
Device Name
PainBlocker™ 18g x 3"" Hemi Cryoneuroablation Probe FDA UDI
Model / Reference
410-182H FDA UDI
Description
PainBlocker™ 18g x 3"" Hemi Cryoneuroablation Probe FDA UDI

Identifiers

Catalog Number
410-182H FDA UDI
Primary DI / UDI-DI
00818788021953 FDA UDI
FDA Product Code
GXH FDA UDI
GMDN Term
Cryogenic analgesia unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.043 Inch FDA UDI
Length — 3 Inch FDA UDI

Category: Cryogenic analgesia unit

Epimed by Epimed International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cryogenic analgesia unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epimed International, Inc

Sources (1)

  • FDA UDI c9d6f5e7-9ad5-4373-8a06-eef849aa5d05 37 fields · synced Jun 8, 2026