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PTFE Peelable Introducer Kit

FDA UDI

Class II (US FDA UDI)

by Greatbatch Ltd

Identity

Trade Name
PTFE Peelable Introducer Kit FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Model / Reference
7142 FDA UDI

Identifiers

Primary DI / UDI-DI
00802526486128 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1340 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

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

Dimensions & Sizes

Size
Outer Diameter — 0.89 Millimeter FDA UDI
Length — 60 Centimeter FDA UDI
Needle Gauge — 18 Gauge FDA UDI
Total Volume — 12 Milliliter FDA UDI
Lumen/Inner Diameter — 2.6 Millimeter FDA UDI
Length — 25 Centimeter FDA UDI

Category: Vascular catheter introduction set, nonimplantable

PTFE Peelable Introducer Kit by Greatbatch Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheter introduction set, nonimplantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Greatbatch Ltd

Sources (1)

  • FDA UDI 47b8d401-0310-4c30-b20a-bbfdfbadc4c1 34 fields · synced Jun 1, 2026