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Dac 070

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
DAC 070 FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
Distal Access Catheter FDA UDI
Model / Reference
90770 FDA UDI
Description
Distal Access Catheter FDA UDI

Identifiers

Catalog Number
90770 FDA UDI
Primary DI / UDI-DI
07613327313932 FDA UDI
510(k) Number
K133177 FDA UDI
FDA Product Code
DQO FDA UDI
DQY FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
870.1250 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

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

Dimensions & Sizes

Size
Length — 105.0 Centimeter FDA UDI
Lumen/Inner Diameter — 0.07 Inch FDA UDI
Catheter Gauge — 6.3 French FDA UDI

Category: Vascular guide-catheter, single-use

Dac 070 by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Cleared under the same submission

K133177 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 249602e8-15de-49be-931d-ee917935af33 38 fields · synced May 31, 2026