SURESPACE

GUDID 00822409043194

FEMORAL SPACER MOLD MEDIUM

Ortho Development Corporation

Orthopaedic cement spacer mould
Primary Device ID00822409043194
NIH Device Record Keyb6bb7ba1-baab-4466-85cd-272d916de90c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURESPACE
Version Model NumberSSF1067
Company DUNS876542390
Company NameOrtho Development Corporation
Device Count1
DM Exempttrue
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

Customer Support Contacts

Phone+1(801)553-9991
Emailcustomerservice@odev.com

Device Dimensions

Width67 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100822409043194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBBBONE CEMENT, ANTIBIOTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-14
Device Publish Date2019-10-04

On-Brand Devices [SURESPACE]

00822409043231TIBIAL SPACER MOLD LARGE
00822409043224TIBIAL SPACER MOLD MEDIUM
00822409043217TIBIAL SPACER MOLD SMALL
00822409043200FEMORAL SPACER MOLD LARGE
00822409043194FEMORAL SPACER MOLD MEDIUM
00822409043187FEMORAL SPACER MOLD SMALL

Trademark Results [SURESPACE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURESPACE
SURESPACE
88536225 not registered Live/Pending
Depuy Synthes, Inc.
2019-07-25

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