ASPHERE 136506100

GUDID 10603295032991

ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm +5 OFFSET

DEPUY (IRELAND)

Metallic femoral head prosthesis
Primary Device ID10603295032991
NIH Device Record Keybc11984e-a3cc-4d3c-a02f-8edc65ca777e
Commercial Distribution StatusIn Commercial Distribution
Brand NameASPHERE
Version Model Number1365-06-100
Catalog Number136506100
Company DUNS989365556
Company NameDEPUY (IRELAND)
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

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110603295032991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-06
Device Publish Date2015-03-24

On-Brand Devices [ASPHERE]

10603295034247ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 44mm +12 OFFSET
10603295034001ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +15.5 OFFSET
10603295033981ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +12 OFFSET
10603295033967ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +8.5 OFFSET
10603295033943ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +5 OFFSET
10603295033929ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +1.5 OFFSET
10603295033905ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm -2 OFFSET
10603295033806ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 40mm +6 OFFSET
10603295033783ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 40mm +3 OFFSET
10603295033769ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 40mm +0 OFFSET
10603295033554ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +12 OFFSET
10603295033530ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +9 OFFSET
10603295033516ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +6 OFFSET
10603295033394ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +3 OFFSET
10603295033370ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +0 OFFSET
10603295033233ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm -3 OFFSET
10603295033011ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm +8.5 OFFSET
10603295032991ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm +5 OFFSET
10603295032977ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm +1.5 OFFSET
10603295032953ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm -2 OFFSET

Trademark Results [ASPHERE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASPHERE
ASPHERE
97836856 not registered Live/Pending
Go Fresh Trading Inc
2023-03-13
ASPHERE
ASPHERE
77536319 3737782 Dead/Cancelled
DePuy, Inc.
2008-07-31

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