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Achieve®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
Achieve® FDA UDI
Generic Name
Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Model / Reference
10884450444433 FDA UDI

Identifiers

Catalog Number
CA1815/B FDA UDI
Primary DI / UDI-DI
10884450444433 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Soft-tissue biopsy procedure kit, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1075 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Soft-tissue biopsy procedure kit, non-medicated

Achieve is a high-quality, single-use soft-tissue biopsy procedure kit designed for gastroenterologists and urologists. This device features a sterile biopsy needle, is suitable for implantable use, and has been certified as compliant with FDA regulations. With its compact size and ease of use, Achieve makes it an ideal solution for patients seeking a non-medicated biopsy option.

Similar devices

Also classified as Soft-tissue biopsy procedure kit, non-medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 5896c23a-25c3-464e-9817-d8555249aa5d 34 fields · synced Oct 6, 2026