REFLECTION, MICROSTABLE 71334524

GUDID 00885556019979

REFLECTION XLPE 28 20 D ANTEVERTED +4 50-52 E ETO

Smith & Nephew, Inc.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00885556019979
• NIH Device Record Key: 1347de88-a286-4065-b7d0-468095ab3511
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFLECTION, MICROSTABLE
• Version Model Number: 71334524
• Catalog Number: 71334524
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556019979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002747

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [REFLECTION, MICROSTABLE]

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