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PremierPro

FDA UDI

Class I (US FDA UDI)

by Svs Llc

Identity

Trade Name
PremierPro FDA UDI
Generic Name
Radiopaque woven surgical sponge, non-sterile FDA UDI
Device Name
PremierPro Lap Sponge 4"x18" Non-Sterile, 5/pk FDA UDI
Model / Reference
X8415NS FDA UDI
Description
PremierPro Lap Sponge 4"x18" Non-Sterile, 5/pk FDA UDI

Identifiers

Catalog Number
X8415NS FDA UDI
Primary DI / UDI-DI
00818566012333 FDA UDI
FDA Product Code
GDY FDA UDI
GMDN Term
Radiopaque woven surgical sponge, non-sterile FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiopaque woven surgical sponge, non-sterile

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

Similar devices

Also classified as Radiopaque woven surgical sponge, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Svs Llc

Sources (1)

  • FDA UDI eff19b65-d95a-40d1-8675-864abaaba3c1 35 fields · synced Jun 8, 2026