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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
Suturing needle holder, reusable FDA UDI
Device Name
Needle Holder, Mini-Ryder Straight 15cm FDA UDI
Model / Reference
Z-4321 FDA UDI
Description
Needle Holder, Mini-Ryder Straight 15cm FDA UDI

Identifiers

Primary DI / UDI-DI
00840105218197 FDA UDI
FDA Product Code
HXK FDA UDI
GMDN Term
Suturing needle holder, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
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

Category: Suturing needle holder, reusable

The ZOLL-DENTAL needle holder is a hand-held, reusable medical device designed to facilitate precise and efficient suturing procedures. This device features adjustable jaws that securely grasp a suture needle, allowing for smooth and controlled tissue manipulation. The ergonomic design ensures comfortable grip and reduced fatigue during extended use.

Similar devices

Also classified as Suturing needle holder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zoll-Dental

Sources (1)

  • FDA UDI b14b6414-5000-45f9-861d-97276f0e45e7 34 fields · synced Jul 11, 2026