← Back to catalogue

Hydra Jagwire™

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref M00556050

by Boston Scientific Corporation

Identity

Trade Name
Hydra Jagwire™ EUDAMED
Hydra Jagwire FDA UDI
Generic Name
Gastro-urological guidewire, single-use FDA UDI
Device Name
Hydra Jagwire EUDAMED
High Performance Guidewire FDA UDI
Model / Reference
M00556050 EUDAMEDFDA UDI
Description
High Performance Guidewire FDA UDI

Identifiers

Primary DI / UDI-DI
08714729747109 EUDAMEDFDA UDI
Basic UDI-DI
01915060000000000000528NF EUDAMED
FDA Product Code
EZB FDA UDI
EMDN Code
G0399 DIGESTIVE ENDOSCOPY DEVICES - OTHER EUDAMED
GMDN Term
Gastro-urological guidewire, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
876.5130 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

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Hydra Jagwire™ by Boston Scientific Corporation — 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
Boston Scientific Corporation
EUDAMED SRN
US-MF-000004702
Authorised Representative
Boston Scientific Limited IE-AR-000003840

Sources (2)

  • EUDAMED 9c928f83-3449-4142-a7b2-ed3f2949bb24 61 fields · synced Jun 20, 2026
  • FDA UDI 7cb33c92-bd82-450b-9d96-a1227d377c46 34 fields · synced May 29, 2026