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Zoll-Dental

FDA UDI

Class I (US FDA UDI)

by Zoll-Dental

Identity

Trade Name
ZOLL-DENTAL FDA UDI
Generic Name
Dental material injection cannula, reusable FDA UDI
Device Name
Bone Carrier 6.0mm FDA UDI
Model / Reference
Z-6504 FDA UDI
Description
Bone Carrier 6.0mm FDA UDI

Identifiers

Primary DI / UDI-DI
00840105219804 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental material injection cannula, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Zoll-Dental by Zoll-Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zoll-Dental

Sources (1)

  • FDA UDI d438f155-a329-44ce-857b-e162083c9ffc 35 fields · synced Jun 6, 2026