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Endocraft LLC

FDA UDI

Class I (US FDA UDI)

by Endocraft LLC

Identity

Trade Name
Endocraft LLC FDA UDI
Generic Name
Laryngeal injection kit FDA UDI
Device Name
Zeitels Vocal Fold Infusion Needles are designed for vocal surgery for injection of needed fluid to surgical site. FDA UDI
Model / Reference
ZIN-100A FDA UDI
Description
Zeitels Vocal Fold Infusion Needles are designed for vocal surgery for injection of needed fluid to surgical site. FDA UDI

Identifiers

Catalog Number
ZIN-100A FDA UDI
Primary DI / UDI-DI
00860009975156 FDA UDI
FDA Product Code
KAA FDA UDI
GMDN Term
Laryngeal injection kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laryngeal injection kit

Endocraft LLC by Endocraft LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laryngeal injection kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endocraft LLC

Sources (1)

  • FDA UDI 5adaba78-9aa0-4c84-929c-71276ab74736 35 fields · synced May 30, 2026