Ambler Value Line

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Value Line FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: Castroviejo needle holder, 5 3/8'', curved, medium jaws, flat handle, without lock, economy pattern recommended for clinics/mission trips only FDA UDI
Model / Reference: Castroviejo needle holder FDA UDI
Description: Castroviejo needle holder, 5 3/8'', curved, medium jaws, flat handle, without lock, economy pattern recommended for clinics/mission trips only FDA UDI

Identifiers

Catalog Number: EC4458 FDA UDI
Primary DI / UDI-DI: 00190660196721 FDA UDI
FDA Product Code: HNR FDA UDI
GMDN Term: Suturing needle holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Suturing needle holder, reusable

Ambler Value Line by Ambler Surgical, LLC — 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: Ambler Surgical, LLC

Sources (1)

FDA UDI da86ce38-5552-4d45-8274-cf9bef59b26a 35 fields · synced Jun 8, 2026