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ProTector

FDA UDI

Class II (US FDA UDI)

by MicroCare, LLC

Identity

Trade Name
ProTector FDA UDI
Generic Name
Surgical instrument interim-placement holder, single-use FDA UDI
Device Name
Needle Sheath Prop FDA UDI
Model / Reference
PNS500 FDA UDI
Description
Needle Sheath Prop FDA UDI

Identifiers

Catalog Number
PNS500-1 FDA UDI
Primary DI / UDI-DI
H816MPNS5001 FDA UDI
510(k) Number
K052725 FDA UDI
FDA Product Code
FMI FDA UDI
GMDN Term
Surgical instrument interim-placement holder, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5570 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical instrument interim-placement holder, single-use

ProTector by MicroCare, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument interim-placement holder, single-use.

Cleared under the same submission

K052725 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MicroCare, LLC

Sources (1)

  • FDA UDI 68fc959f-01d8-42b4-a95f-7fb86837de65 35 fields · synced May 30, 2026