ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED 100-20-014

GUDID 00841176100282

ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 14

STINSON ORTHOPEDICS INC.

Coated femoral stem prosthesis, modular
Primary Device ID00841176100282
NIH Device Record Key34da888f-c66d-4f22-a5a0-3eac1dce4bd1
Commercial Distribution StatusIn Commercial Distribution
Brand NameENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED
Version Model Number100-20-014
Catalog Number100-20-014
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
GS100841176100282 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-12-26

On-Brand Devices [ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED]

00841176100312ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 18
00841176100305ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 16
00841176100299ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 15
00841176100282ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 14
00841176100275ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 13
00841176100268ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 12
00841176100251ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 11
00841176100244ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 10
00841176100237ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 9
00841176100220ENCINA HA FEMORAL STEM STANDARD OFFSET COLLARED, SZ 8

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