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Protective Bag Size 2 100 Pcs

FDA UDI

Class II (US FDA UDI)

by PaloDEx Group Oy

Identity

Trade Name
PROTECTIVE BAG SIZE 2 100 PCS FDA UDI
Generic Name
Medical equipment drape, single-use, non-sterile FDA UDI
Model / Reference
9802391 FDA UDI

Identifiers

Primary DI / UDI-DI
06430035873654 FDA UDI
510(k) Number
K133231 FDA UDI
FDA Product Code
PEM FDA UDI
GMDN Term
Medical equipment drape, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical equipment drape, single-use, non-sterile

Protective Bag Size 2 100 Pcs by PaloDEx Group Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment drape, single-use, non-sterile.

Cleared under the same submission

K133231 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PaloDEx Group Oy

Sources (1)

  • FDA UDI 4151e7f8-8088-493d-925d-2c5b14cadcbe 33 fields · synced May 30, 2026