R3, STIKTITE 71338667

GUDID 00885556021934

R3 MULTI HOLE ACETABULAR SHELL 56MM

Smith & Nephew, Inc.

Acetabular shell

• Primary Device ID: 00885556021934
• NIH Device Record Key: 94048e87-1029-4b16-811c-1b77ce5585f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R3, STIKTITE
• Version Model Number: 71338667
• Catalog Number: 71338667
• 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)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	00885556021934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092386

FDA Product Code

• MBL: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-30

On-Brand Devices [R3, STIKTITE]

• 00885556113684: R3 MULTI-HOLE ACETABULAR SHELL 40MM
• 00885556113677: R3 MULTI-HOLE ACETABULAR SHELL 42MM
• 00885556113271: R3 MULTI-HOLE ACETABULAR SHELL 44MM
• 00885556113264: R3 MULTI HOLE ACET SHELL 46MM
• 00885556022672: R3 MULTI HOLE ACETABULAR SHELL 68MM
• 00885556022214: R3 MULTI HOLE ACET SHELL 58MM
• 00885556022184: R3 MULTI HOLE ACETABULAR SHELL 66MM
• 00885556022153: R3 MULTI HOLE ACETABULAR SHELL 76MM
• 00885556021941: R3 MULTI HOLE ACET SHELL 48MM
• 00885556021934: R3 MULTI HOLE ACETABULAR SHELL 56MM
• 00885556021804: R3 MULTI HOLE ACETABULAR SHELL 54MM
• 00885556021781: R3 MULTI HOLE ACETABULAR SHELL 64MM
• 00885556021705: R3 MULTI HOLE ACETABULAR SHELL 74MM
• 00885556021583: R3 MULTI HOLE ACETABULAR SHELL 78MM
• 00885556021491: R3 MULTI HOLE ACETABULAR SHELL 52MM
• 00885556021224: R3 MULTI HOLE ACETABULAR SHELL 72MM
• 00885556020968: R3 MULTI HOLE ACETABULAR SHELL 62MM
• 00885556020647: R3 MULTI HOLE ACETABULAR SHELL 70MM
• 00885556020630: R3 MULTI HOLE ACET SHELL 50MM
• 00885556020364: R3 MULTI HOLE ACETABULAR SHELL 60MM
• 00885556019795: R3 MULTI HOLE ACETABULAR SHELL 80MM
• 03596010598219: R3 3 HOLE ACETABULAR SHELL 46MM
• 03596010598202: R3 3 HOLE ACETABULAR SHELL 44MM
• 03596010598196: R3 3 HOLE ACETABULAR SHELL 42MM
• 03596010598189: R3 3 HOLE ACETABULAR SHELL 40MM
• 03596010597564: R3 0 HOLE ACETABULAR SHELL 46MM
• 03596010597557: R3 0 HOLE ACETABULAR SHELL 44MM
• 03596010597540: R3 0 HOLE ACETABULAR SHELL 42MM
• 03596010597533: R3 0 HOLE ACETABULAR SHELL 40MM