REFLECTION, MICROSTABLE 71934294

GUDID 00885556143094

REFLECTION LINER XLPE 40 ID 20 DEG ANT +4 62-64 H

Smith & Nephew, Inc.

Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner
Primary Device ID00885556143094
NIH Device Record Key7b312a9c-821f-4441-a50a-019d6663fb8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameREFLECTION, MICROSTABLE
Version Model Number71934294
Catalog Number71934294
Company DUNS109903521
Company NameSmith & Nephew, 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 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)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556143094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZPCLIP, IMPLANTABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-29

On-Brand Devices [REFLECTION, MICROSTABLE]

00885556143117REFLECTION LINER XLPE 36 ID 20 DEG ANT +6 50-52 E
00885556143100REFLECTION XLPE 40 20 DEG ANTEVERTED +4 58-60 G
00885556143094REFLECTION LINER XLPE 40 ID 20 DEG ANT +4 62-64 H
00885556143087TRIAL REFLECTION LINER XLPE 36 ID 20 DEG ANT +6 50-52 E
00885556143070TRIAL REFLECTION LINER XLPE 40 ID 20 DEG ANT +4 58-60 G
00885556143063TRIAL REFLECTION LINER XLPE 40 ID 20 DEG ANT +4 62-64 H
00885556058169REFLECTION LINER XLPE 36MM 20 DEG ANT +6 58-60 G
00885556057865REFLECTION LINER XLPE 36MM 20 DEG ANT +6 54-56 F
00885556022771REFLECTION XLPE 35 32 62-64
00885556022528REFLECTION XLPE 35 32 58-60
00885556022498REFLECTION XLPE 26 20 DEG ANTEVERTED +4 62-64 H
00885556022177REFLECTION XLPE 35 32 54-56
00885556022092REFLECTION XLPE 22 0 DEG LATERALIZED +4 54-56 F
00885556021965REFLECTION XLPE 26 20 DEG ANTEVERTED +4 58-60 G
00885556021897REFLECTION XLPE 26 20 DEG ANTEVERTED +4 54-56 F
00885556021866REFLECTION XLPE 35 36 66-68
00885556021842REFLECTION XLPE 26 20 DEG ANTEVERTED +4 44 C
00885556021811REFLECTION XLPE 26 20 D ANTEVERTED +4 44 C ETO
00885556021774REFLECTION XLPE 22 20 EG ANTEVERTED +4 54-56 F
00885556021743REFLECTION XLPE 35 36 62-64
00885556021736REFLECTION XLPE 22 0 DEG LATERALIZED +4 50-52 E
00885556021613REFLECTION XLPE 22 0 DEG LATERALIZED +4 40 A
00885556021545REFLECTION XLPE 28 0 D LATERALIZED +4 54-56 F ETO
00885556021460REFLECTION XLPE 22 20 DEG ANTEVERTED +4 44 C ETO
00885556021446REFLECTION XLPE 28 20 D ANTEVERTED +4 46-48 D ETO
00885556021347REFLECTION XLPE 26 0 DEG LATERALIZED +4 62-64 H
00885556021200REFLECTION XLPE 26 0 DEG LATERALIZED +4 44 C
00885556021194REFLECTION XLPE 26 0 DEG LATERALIZED +4 58-60 G
00885556021187REFLECTION XLPE 35 36 58-60
00885556021170REFLECTION XLPE 22 20 DEG ANTEVERTED +4 40 A
00885556021149REFLECTION XLPE 22 20 DEG ANTEVERTED +4 50-52 E
00885556021095REFLECTION XLPE 28 20 D ANTEVERTED +4 62-64 H ETO
00885556021057REFLECTION XLPE 28 0 D LATERALIZED +4 50-52 E ETO
00885556020944REFLECTION XLPE 22 20 DEG ANTEVERTED +4 66-68 J
00885556020890REFLECTION XLPE 26 20 D ANTEVERTED +4 54-56 F ETO
00885556020883REFLECTION XLPE 26 0 D LATERALIZED +4 44 C ETO
00885556020807REFLECTION XLPE 26 0 DEG LATERALIZED +4 54-56 F
00885556020777REFLECTION XLPE 35 28 50-52
00885556020760REFLECTION XLPE 26 20 DEG ANTEVERTED +4 50-52 E
00885556020715REFLECTION XLPE 22 0 DEG LATERALIZED +4 46-48 D
00885556020593REFLECTION XLPE 22 20 DEG ANTEVERTED +4 46-48 D
00885556020579REFLECTION XLPE 28 0 D LATERALIZED +4 46-48 D ETO
00885556020555REFLECTION XLPE 22 20 DEG ANTEVERTED +4 62-64 H
00885556020524REFLECTION XLPE 22 0 DEG LATERALIZED +4 44 C
00885556020517REFLECTION XLPE 35 28 46-48
00885556020487REFLECTION XLPE 28 0 D LATERALIZED +4 58-60 G ETO
00885556020463REFLECTION XLPE 28 20 D ANTEVERTED +4 58-60 G ETO
00885556020425REFLECTION XLPE 22 0 DEG LATERALIZED +4 44 C ETO
00885556020418REFLECTION XLPE 26 20 D ANTEVERTED +4 50-52 E ETO
00885556020401REFLECTION XLPE 26 0 DEG LATERALIZED +4 50-52 E
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