← Back to catalogue

Herculink Elite

FDA UDI

Class III (US FDA UDI)

by Abbott Vascular

Identity

Trade Name
Herculink Elite FDA UDI
Generic Name
Peripheral artery stent, bare-metal FDA UDI
Device Name
RX Herculink Elite Renal and Biliary Stent System 4.0 mm x 12 mm x 135 cm FDA UDI
Model / Reference
1011487-12 FDA UDI
Description
RX Herculink Elite Renal and Biliary Stent System 4.0 mm x 12 mm x 135 cm FDA UDI

Identifiers

Catalog Number
1011487-12 FDA UDI
Primary DI / UDI-DI
08717648077821 FDA UDI
FDA Product Code
NIN FDA UDI
GMDN Term
Peripheral artery stent, bare-metal FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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 Conditional FDA UDI

Category: Peripheral artery stent, bare-metal

Herculink Elite by Abbott Vascular — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral artery stent, bare-metal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Abbott Vascular

Sources (1)

  • FDA UDI 9fc9a588-705b-433b-915a-177387857a97 36 fields · synced Jun 1, 2026