Duraholder

FDA UDI

Class I (US FDA UDI)

by Precision Dynamics Corporation

Identity

Trade Name: Duraholder FDA UDI
Generic Name: Personal device holder, single-use FDA UDI
Device Name: Duraholder 16x18.5 inches 6 Pockets, 2 Rows, 100 Case; Instrument Holder FDA UDI
Model / Reference: Y5647879 FDA UDI
Description: Duraholder 16x18.5 inches 6 Pockets, 2 Rows, 100 Case; Instrument Holder FDA UDI

Identifiers

Catalog Number: PDC-DURA300/100 FDA UDI
Primary DI / UDI-DI: 10687225799048 FDA UDI
FDA Product Code: MDM FDA UDI
GMDN Term: Personal device holder, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Personal device holder, single-use

Duraholder by Precision Dynamics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Precision Dynamics Corporation

Sources (1)

FDA UDI d74e3c30-c7ed-4691-99eb-f67b335fe3fc 34 fields · synced Jun 8, 2026