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ProView plus

FDA UDI

Class II (US FDA UDI)

by Certol International, Llc

Identity

Trade Name
ProView plus FDA UDI
Generic Name
Sterilization packaging, single-use FDA UDI
Device Name
Self-Sealing Sterilization Pouch/Packaging 13" X 18" FDA UDI
Model / Reference
PM1318 FDA UDI
Description
Self-Sealing Sterilization Pouch/Packaging 13" X 18" FDA UDI

Identifiers

Catalog Number
PM1318-1 FDA UDI
Primary DI / UDI-DI
H816PM13191 FDA UDI
510(k) Number
K953829 FDA UDI
FDA Product Code
KCT FDA UDI
GMDN Term
Sterilization packaging, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

ProView plus by Certol International, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K953829 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Certol International, Llc

Sources (1)

  • FDA UDI e3301599-6250-49b0-98e7-e59d7b88088c 36 fields · synced Jun 6, 2026