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PremierPro

FDA UDI

Class II (US FDA UDI)

by Svs Llc

Identity

Trade Name
PremierPro FDA UDI
Generic Name
Blood lancet, single-use FDA UDI
Device Name
Safety Lancet Heel Incision Micro-Preemie, Green FDA UDI
Model / Reference
7511 FDA UDI
Description
Safety Lancet Heel Incision Micro-Preemie, Green FDA UDI

Identifiers

Catalog Number
7511 FDA UDI
Primary DI / UDI-DI
00818566013422 FDA UDI
FDA Product Code
FMK FDA UDI
GMDN Term
Blood lancet, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4850 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

No

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

Dimensions & Sizes

Size
Depth — 0.65 Millimeter FDA UDI
Length — 1.4 Millimeter FDA UDI

Category: Blood lancet, single-use

PremierPro by Svs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood lancet, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Svs Llc

Sources (1)

  • FDA UDI d1ec09fb-c676-4acf-b225-3f7f668ba5b9 36 fields · synced May 30, 2026