Washer, Flat 36431

GUDID 09120034306327

Washer, Flat, AD=11,0mm, ID=4,5mm

I.T.S. GmbH

Implantable bone washer
Primary Device ID09120034306327
NIH Device Record Key4fcb45f8-33e2-4cc1-95e6-9a1f58c3eedf
Commercial Distribution StatusIn Commercial Distribution
Brand NameWasher, Flat
Version Model Number36431
Catalog Number36431
Company DUNS303456917
Company NameI.T.S. GmbH
Device Count1
DM Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120034306327 [Primary]

FDA Product Code

HTNWasher, Bolt Nut

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


[09120034306327]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-09-18
Device Publish Date2016-09-12

On-Brand Devices [Washer, Flat]

09120034308444Washer, Flat, AD=15,0mm, ID=7,5mm
09120034306327Washer, Flat, AD=11,0mm, ID=4,5mm
09120034304644Washer, Flat, AD=12,6,0mm, ID=7,0mm
09120034304392Washer, Flat, AD=14,0mm, ID=7,0mm

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