FIRSTPASSST 22-4038

GUDID 00817470012309

DISP FIRSTPASS STR PASSR SELF

Smith & Nephew, Inc.

Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable
Primary Device ID00817470012309
NIH Device Record Key6165d9bb-a157-4418-9a12-4b6d7186a7f2
Commercial Distribution Discontinuation2018-09-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFIRSTPASSST
Version Model Number22-4038
Catalog Number22-4038
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100817470012309 [Primary]

FDA Product Code

HWQPASSER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-06
Device Publish Date2017-11-13

On-Brand Devices [FIRSTPASSST]

00817470012316DFP SUTURE PASSER STANDARD
00817470012309DISP FIRSTPASS STR PASSR SELF

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