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Dexterity Steerable Introducer

FDA UDI

Class II (US FDA UDI)

by Primo Medical Group

Identity

Trade Name
Dexterity Steerable Introducer FDA UDI
Generic Name
Cardiac transseptal access set FDA UDI
Device Name
FG 9Fr Dexterity Introducer 75cm 2-0 Tip FDA UDI
Model / Reference
9 Fr x 75 cm FDA UDI
Description
FG 9Fr Dexterity Introducer 75cm 2-0 Tip FDA UDI

Identifiers

Catalog Number
60-0031-20 FDA UDI
Primary DI / UDI-DI
00864795000108 FDA UDI
510(k) Number
K120086 FDA UDI
FDA Product Code
DRA FDA UDI
DYB FDA UDI
GMDN Term
Cardiac transseptal access set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1280 FDA UDI
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

No

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

Category: Cardiac transseptal access set

Dexterity Steerable Introducer by Primo Medical Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac transseptal access set.

Cleared under the same submission

K120086 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Primo Medical Group

Sources (1)

  • FDA UDI ff5468a6-0fd3-4163-85bb-4d97d9e47a5b 36 fields · synced Jun 6, 2026