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Impact™

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
Impact™ FDA UDI
Generic Name
Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name
IMPACT BALLOON CATHETER 12MMX2CMX120CM FDA UDI
Model / Reference
122120 FDA UDI
Description
IMPACT BALLOON CATHETER 12MMX2CMX120CM FDA UDI

Identifiers

Catalog Number
122120 FDA UDI
Primary DI / UDI-DI
04046964290510 FDA UDI
510(k) Number
K931009 FDA UDI
FDA Product Code
KNQ FDA UDI
LIT FDA UDI
GMDN Term
Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5365 FDA UDI
870.1250 FDA UDI
Commercial Distribution
Not 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

Impact™ by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K931009 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B Braun Interventional Systems, Inc

Sources (1)

  • FDA UDI 2901c70c-0a9e-4d99-a017-76cd73eca05a 38 fields · synced May 30, 2026