ACP

GUDID 08033726407152

SINTEA PLUSTEK SRL

Spinal fixation plate, non-bioabsorbable
Primary Device ID08033726407152
NIH Device Record Keyb348a955-3252-4e4d-9aa0-d26699564012
Commercial Distribution StatusIn Commercial Distribution
Brand NameACP
Version Model NumberACP-20T51
Company DUNS544150399
Company NameSINTEA PLUSTEK SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033726407152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


[08033726407152]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2015-10-06

On-Brand Devices [ACP]

08057432565746ACP-04T526
08057432565739ACP-04T525
08057432560796ACP-01T512
08033726409835ACP-04T524
08033726409828ACP-04T523
08033726409811ACP-04T522
08033726409804ACP-04T521
08033726409798ACP-04T520
08033726409781ACP-04T519
08033726409774ACP-04T518
08033726409767ACP-04T517
08033726409750ACP-04T516
08033726409743ACP-04T515
08033726409736ACP-03T524
08033726409729ACP-03T523
08033726409712ACP-03T522
08033726409705ACP-03T521
08033726409699ACP-03T520
08033726409682ACP-03T519
08033726409675ACP-03T518
08033726409668ACP-03T517
08033726409651ACP-03T516
08033726409644ACP-03T515
08033726409637ACP-02T524
08033726409620ACP-02T523
08033726409613ACP-02T522
08033726409606ACP-02T521
08033726409590ACP-02T520
08033726409583ACP-02T519
08033726409576ACP-02T518
08033726409569ACP-02T517
08033726409552ACP-02T516
08033726409545ACP-02T515
08033726409538ACP-02T514
08033726409521ACP-02T513
08033726409514ACP-01T530
08033726409507ACP-01T528
08033726409491ACP-01T526
08033726409484ACP-01T524
08033726409477ACP-01T522
08033726409460ACP-01T520
08033726409453ACP-01T518
08033726409446ACP-01T516
08033726409439ACP-01T514
08033726407282ACP-20T54
08033726407275ACP-18T54
08033726407268ACP-16T54
08033726407251ACP-14T54
08033726407244ACP-20T53
08033726407237ACP-18T53

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.