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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
Full blood count IVD, calibrator FDA UDI
Model / Reference
1000542-007 FDA UDI

Identifiers

Catalog Number
7133 FDA UDI
Primary DI / UDI-DI
00821329400636 FDA UDI
FDA Product Code
DYB FDA UDI
GMDN Term
Full blood count IVD, calibrator 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 — 4.2 Millimeter FDA UDI
Lumen/Inner Diameter — 0.9 Millimeter FDA UDI
Catheter Gauge — 12 French FDA UDI
Length — 70 Millimeter FDA UDI
Outer Diameter — 1.4 Millimeter FDA UDI
Length — 60 Centimeter FDA UDI
Outer Diameter — 0.89 Millimeter FDA UDI
Length — 25 Centimeter FDA UDI
Lumen/Inner Diameter — 4.1 Millimeter FDA UDI

Category: Full blood count IVD, calibrator

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

Similar devices

Also classified as Full blood count IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Greatbatch Ltd

Sources (1)

  • FDA UDI c9d13e20-b30e-444d-b01b-7d34f74d1e4a 35 fields · synced May 30, 2026