Precision Point Locator

FDA UDI

Class U (US FDA UDI)

by Sientra, Inc.

Identity

Trade Name: Precision Point Locator FDA UDI
Generic Name: Tissue expander injection port locator FDA UDI
Device Name: Precision Point Locator (5 each) FDA UDI
Model / Reference: PPL01 FDA UDI
Description: Precision Point Locator (5 each) FDA UDI

Identifiers

Catalog Number: PPL01 FDA UDI
Primary DI / UDI-DI: 00819409020348 FDA UDI
510(k) Number: K070303 FDA UDI
FDA Product Code: LCJ FDA UDI
GMDN Term: Tissue expander injection port locator 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Tissue expander injection port locator

Precision Point Locator by Sientra, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue expander injection port locator.

TRUSITE® — Pmt Corp. · Class I
MENTOR CENTERSCOPE Magnetic Detection Device — Mentor Texas LP · U
AlloX2 Magnetic Site Locator — Sientra, Inc. · U
SIENTRA Dual Magnetic Port Locator — Sientra, Inc. · U
Tissue Expander Remote Port Accessories — Sientra, Inc. · U

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Sientra, Inc.

Sources (1)

FDA UDI 5d3c089d-d8f9-45c5-a6f1-0e2b39e2b2fb 37 fields · synced May 30, 2026