JAZZ Systems 550404

GUDID 03607505504049

IMPLANET

Surgical implant handling forceps
Primary Device ID03607505504049
NIH Device Record Key770924fb-2fa6-4182-a9d1-cc3ed7b6a49e
Commercial Distribution StatusIn Commercial Distribution
Brand NameJAZZ Systems
Version Model NumberJAZZ CLAW –Snapping Forceps
Catalog Number550404
Company DUNS291993439
Company NameIMPLANET
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS103607505504049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWIBone Fixation Cerclage, Sublaminar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


[03607505504049]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-23
Device Publish Date2020-12-15

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03607506313374 - Jazz Spinal System2025-07-07 Straight rod 5.5x80
03607506313398 - Jazz Spinal System2025-07-07 Straight rod 5.5x90
03607506313411 - Jazz Spinal System2025-07-07 Straight rod 5.5x100
03607506313428 - Jazz Spinal System2025-07-07 Straight rod 5.5x110
03607506313435 - Jazz Spinal System2025-07-07 Straight rod 5.5x120

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