S-ROM 136536000

GUDID 10603295033547

S-ROM M METAL ON METAL FEMORAL HEAD Diameter 36mm +12 11/13 TAPER

DEPUY (IRELAND)

Metallic femoral head prosthesis
Primary Device ID10603295033547
NIH Device Record Key8a789db2-2bb3-4c69-94e7-bd8865843493
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-ROM
Version Model Number1365-36-000
Catalog Number136536000
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
GS110603295033547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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 Date2015-09-24

On-Brand Devices [S-ROM]

10603295327035S-ROM M METAL ON METAL FEMORAL HEAD Diameter 36mm +12 11/13 TAPER
10603295033547S-ROM M METAL ON METAL FEMORAL HEAD Diameter 36mm +12 11/13 TAPER

Trademark Results [S-ROM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
S-ROM
S-ROM
76516840 not registered Dead/Abandoned
JOHNSON & JOHNSON
2003-05-01
S-ROM
S-ROM
74087580 1701594 Live/Registered
JOHNSON & JOHNSON
1990-08-13

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