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Graftsite

FDA UDI

Class II (US FDA UDI)

by Summit Medical, LLC

Identity

Trade Name
GRAFTSITE FDA UDI
Generic Name
Anaesthesia conduction catheter FDA UDI
Device Name
GRAFTSITE Delivery Assistance Device FDA UDI
Model / Reference
D201045 FDA UDI
Description
GRAFTSITE Delivery Assistance Device FDA UDI

Identifiers

Primary DI / UDI-DI
15060238201145 FDA UDI
510(k) Number
K173110 FDA UDI
FDA Product Code
CAZ FDA UDI
BSP FDA UDI
GMDN Term
Anaesthesia conduction catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5140 FDA UDI
868.5150 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

Category: Anaesthesia conduction catheter

Graftsite by Summit Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia conduction catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Summit Medical, LLC

Sources (1)

  • FDA UDI 96c1922c-0c46-4a83-a55d-91173368d5ba 35 fields · synced Jun 8, 2026