Achieve® A1411/B

GUDID 20884450443693

Merit Medical Systems, Inc.

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated
Primary Device ID20884450443693
NIH Device Record Keyd03c6f1e-a607-4475-ac6b-36de00011b21
Commercial Distribution StatusIn Commercial Distribution
Brand NameAchieve®
Version Model Number10884450443696
Catalog NumberA1411/B
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884450443699 [Unit of Use]
GS100884450443699 [Unit of Use]
GS100884450443699 [Unit of Use]
GS100884450443699 [Unit of Use]
GS110884450443696 [Primary]
GS110884450443696 [Primary]
GS110884450443696 [Primary]
GS110884450443696 [Primary]
GS120884450443693 [Package]
Contains: 10884450443696
Package: [12 Units]
In Commercial Distribution
GS120884450443693 [Package]
Contains: 10884450443696
Package: [12 Units]
In Commercial Distribution
GS120884450443693 [Package]
Contains: 10884450443696
Package: [12 Units]
In Commercial Distribution
GS120884450443693 [Package]
Contains: 10884450443696
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWINSTRUMENT, BIOPSY
KNWINSTRUMENT, BIOPSY
KNWINSTRUMENT, BIOPSY
KNWINSTRUMENT, BIOPSY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Achieve®]

2088445044373010884450443733
2088445044378510884450443788
2088445044442310884450444426
2088445044443010884450444433
2088445044432410884450444327
2088445044396910884450443962
2088445044448510884450444488
2088445044370910884450443702
2088445044445410884450444457
2088445044450810884450444501
2088445044393810884450443931
2088445044437910884450444372
2088445044369310884450443696

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