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Integra

FDA UDI

Class U (US FDA UDI)

by Pmt Corp.

Identity

Trade Name
Integra FDA UDI
Generic Name
Mechanical atherectomy system catheter, coronary/peripheral FDA UDI
Device Name
TE, RECTANGLE SHAPE, 2-STAGE, SMOOTH SURFACE, MICRO REMOTE PORT TUBING, 3X7CM, 102CC FILL, 6CM PROJECTION FDA UDI
Model / Reference
3610-625-2 FDA UDI
Description
TE, RECTANGLE SHAPE, 2-STAGE, SMOOTH SURFACE, MICRO REMOTE PORT TUBING, 3X7CM, 102CC FILL, 6CM PROJECTION FDA UDI

Identifiers

Primary DI / UDI-DI
00650551001058 FDA UDI
510(k) Number
K845036 FDA UDI
FDA Product Code
LCJ FDA UDI
GMDN Term
Mechanical atherectomy system catheter, coronary/peripheral FDA UDI

Classification

Device Class
U 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

Yes

FDA UDI

Category: Mechanical atherectomy system catheter, coronary/peripheral

Integra by Pmt Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system catheter, coronary/peripheral.

Cleared under the same submission

K845036 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pmt Corp.

Sources (1)

  • FDA UDI 24e8f085-e4c5-4b35-9946-fd93f68f7cd3 34 fields · synced Jun 1, 2026