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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™ System FDA UDI
Model / Reference
400-PBSYS FDA UDI
Description
PainBlocker™ System FDA UDI

Identifiers

Catalog Number
400-PBSYS FDA UDI
Primary DI / UDI-DI
00818788022721 FDA UDI
510(k) Number
K854334 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

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 80c2354e-be61-40d9-8438-6739a4c2b511 37 fields · synced Jun 4, 2026