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Garrett Vascular Dilator

FDA UDI

Class II (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
GARRETT VASCULAR DILATOR FDA UDI
Generic Name
Vascular dilator, reusable FDA UDI
Device Name
GARRETT VASCULAR DILATOR ARROW TIP FDA UDI
Model / Reference
2700-003P FDA UDI
Description
GARRETT VASCULAR DILATOR ARROW TIP FDA UDI

Identifiers

Primary DI / UDI-DI
B0992700003P0 FDA UDI
510(k) Number
K100518 FDA UDI
FDA Product Code
DWP FDA UDI
GMDN Term
Vascular dilator, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4475 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 8.25 Inch FDA UDI

Garrett Vascular Dilator by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K100518 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sontec Instruments, Inc.

Sources (1)

  • FDA UDI 5ac4a355-c87d-487a-9eef-6996125e9c74 37 fields · synced May 31, 2026