← Back to catalogue

Epimed International, Inc.

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 138-1427Model Flexible Epidural Introducer (FIC)/Blunt Cannula Access (BAC)

by Epimed International, Inc.

Identity

Trade Name
Epimed International,Inc. EUDAMED
Epimed International, Inc. FDA UDI
Generic Name
Non-vascular catheter introduction set FDA UDI
Device Name
Percutaneous Introducer w/ 14g RW x 2.75" B Bevel needle with sidearm injection port and hemostasis valve FDA UDI
Model / Reference
Flexible Epidural Introducer (FIC)/Blunt Cannula Access (BAC) EUDAMED
138-1427 EUDAMEDFDA UDI
Description
Percutaneous Introducer w/ 14g RW x 2.75" B Bevel needle with sidearm injection port and hemostasis valve FDA UDI

Identifiers

Catalog Number
138-1427 FDA UDI
Primary DI / UDI-DI
00818788023698 EUDAMEDFDA UDI
Basic UDI-DI
081878802FEIKH EUDAMED
510(k) Number
K051860 FDA UDI
FDA Product Code
MIA FDA UDI
EMDN Code
A019013 PERCUTANEOUS NEEDLES EUDAMED
GMDN Term
Non-vascular catheter introduction set FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
868.5150 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 2.75 Inch FDA UDI
Needle Gauge — 14 Gauge FDA UDI

Epimed International, Inc. by Epimed International, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Epimed International, Inc.
EUDAMED SRN
US-MF-000010774
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 18161c3a-2ac4-4bc2-a850-2b6b0a466df7 61 fields · synced Jun 4, 2026
  • FDA UDI 29852c02-83f6-41be-8c4d-ad92d57526de 37 fields · synced May 29, 2026