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EpiZact

FDA UDI

Class II (US FDA UDI)

by Guidestar Medical Devices

Identity

Trade Name
EpiZact FDA UDI
Generic Name
Low-resistance epidural syringe FDA UDI
Device Name
EpiZact is a single use medical device used during an epidural procedure. FDA UDI
Model / Reference
GMD1-001 FDA UDI
Description
EpiZact is a single use medical device used during an epidural procedure. FDA UDI

Identifiers

Primary DI / UDI-DI
00860011139607 FDA UDI
510(k) Number
K233056 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
Low-resistance epidural syringe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 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

Category: Low-resistance epidural syringe

EpiZact by Guidestar Medical Devices — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Low-resistance epidural syringe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Guidestar Medical Devices

Sources (1)

  • FDA UDI 00a1ed26-3ca1-4678-abfd-c73535d5228d 35 fields · synced Jun 8, 2026