ENCINA HA FEMORAL STEM HIGH OFFSET 100-10-011

GUDID 00841176100152

ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 11

STINSON ORTHOPEDICS INC.

Coated femoral stem prosthesis, modular
Primary Device ID00841176100152
NIH Device Record Keycaac34fb-4c07-4ff2-9352-8d02a1615f7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameENCINA HA FEMORAL STEM HIGH OFFSET
Version Model Number100-10-011
Catalog Number100-10-011
Company DUNS080460688
Company NameSTINSON ORTHOPEDICS INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841176100152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-26

On-Brand Devices [ENCINA HA FEMORAL STEM HIGH OFFSET]

00841176100213ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 18
00841176100206ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 16
00841176100190ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 15
00841176100183ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 14
00841176100176ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 13
00841176100169ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 12
00841176100152ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 11
00841176100145ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 10
00841176100138ENCINA HA FEMORAL STEM HIGH OFFSET, SZ 9

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