← Back to catalogue

Guide Wire 3mm J Tip 0.018" x 145 cm PTFE Coated (Type L) Mandrel Wire w/ silico

FDA UDI

Class II (US FDA UDI)

by Datascope Corp.

Identity

Trade Name
Guide Wire 3mm J Tip 0.018" x 145 cm PTFE Coated (Type L) Mandrel Wire w/ silico FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
Guide Wire 3mm J Tip 0.018" x 145 cm PTFE Coated (Type L) Mandrel Wire w/ silicone overcoat FDA UDI
Model / Reference
0684-00-0254-16 FDA UDI
Description
Guide Wire 3mm J Tip 0.018" x 145 cm PTFE Coated (Type L) Mandrel Wire w/ silicone overcoat FDA UDI

Identifiers

Catalog Number
0684-00-0254-16 FDA UDI
Primary DI / UDI-DI
10607567106663 FDA UDI
510(k) Number
K943896 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
Commercial Distribution
Not 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

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

Dimensions & Sizes

Size
Outer Diameter — 0.018 Inch FDA UDI
Length — 145 Centimeter FDA UDI

Guide Wire 3mm J Tip 0.018" x 145 cm PTFE Coated (Type L) Mandrel Wire w/ silico by Datascope Corp. — Class II — FDA UDI — listed in FDA GUDID

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
Datascope Corp.

Sources (1)

  • FDA UDI debcae97-68cf-47e6-a6cc-36e57a4aa320 38 fields · synced May 30, 2026