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PTFE Peelable Introducer Kit

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
667091-351 FDA UDI

Identifiers

Catalog Number
7091 FDA UDI
Primary DI / UDI-DI
00821329000355 FDA UDI
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

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 — 70 Millimeter FDA UDI
Lumen/Inner Diameter — 2.7 Millimeter FDA UDI
Total Volume — 12 Milliliter FDA UDI
Needle Gauge — 18 Gauge FDA UDI
Length — 60 Centimeter FDA UDI
Outer Diameter — 2.9 Millimeter FDA UDI
Catheter Gauge — 8 French FDA UDI
Lumen/Inner Diameter — 0.9 Millimeter FDA UDI
Length — 14 Centimeter FDA UDI

Category: Vascular catheter introduction set, nonimplantable

PTFE Peelable Introducer Kit by Greatbatch Ltd — 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 d501485f-7cf1-47cd-bbd3-cce7f97df230 35 fields · synced May 30, 2026