GUIDOR easy-graft CLASSIC C11-008

GUDID 07640164360645

in situ hardening synthetic bone graft system, 0.4 Milliliter

Degradable Solutions AG

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Primary Device ID07640164360645
NIH Device Record Keyc44d526a-896e-4d6f-a24e-213e250eace7
Commercial Distribution StatusIn Commercial Distribution
Brand NameGUIDOR easy-graft CLASSIC
Version Model NumberC11-008
Catalog NumberC11-008
Company DUNS482821667
Company NameDegradable Solutions AG
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 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

Device Dimensions

Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter
Total Volume0.4 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640164360072 [Previous]
GS107640164360645 [Primary]
GS117640164362417 [Package]
Package: [3 Units]
In Commercial Distribution

FDA Product Code

LYCBone Grafting Material, Synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-10
Device Publish Date2022-05-02

On-Brand Devices [GUIDOR easy-graft CLASSIC]

07640164364544in situ hardening synthetic bone graft system, 0.15 Milliliter
07640164361819in situ hardening synthetic bone graft system, 0.25 Milliliter
07640164360645in situ hardening synthetic bone graft system, 0.4 Milliliter

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