EVOS E0016688-2

GUDID 00885556769126

2.5MM SHORT FIXED/VA GUIDE

Smith & Nephew, Inc.

Surgical drill guide, reusable

• Primary Device ID: 00885556769126
• NIH Device Record Key: 9699aa66-00a8-40c1-be30-596d9288d1c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOS
• Version Model Number: E0016688-2
• Catalog Number: E0016688-2
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556769126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132886

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

[00885556769126]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-29
• Device Publish Date: 2019-10-21

On-Brand Devices [EVOS]

• 00885556732342: LONG T8 DRIVER SHAFT AO QC
• 00885556732335: LONG T7 DRIVER SHAFT AO QC
• 00885556732328: LONG T6 DRIVER SHAFT AO QC
• 00885556731635: T4TORX DRIVER SHORT
• 00885556731628: T6 TORX DRIVER SHORT
• 00885556731611: T7 TORX DRIVER SHORT
• 00885556718186: EVOS DISTAL RADIUS VOLAR PLATE 10H LEFT STANDARD 138MM
• 00885556718179: EVOS DISTAL RADIUS VOLAR PLATE 10H RIGHT STANDARD 138MM
• 00885556718162: EVOS DISTAL RADIUS VOLAR PLATE 10H RIGHT STANDARD 138MM
• 00885556718155: EVOS DISTAL RADIUS VOLAR PLATE 10H LEFT STANDARD 138MM
• 00885556717653: EVOS DISTAL RADIUS VOLAR PLATE 10H LEFT STANDARD TITANIUM 14
• 00885556714232: EVOS DISTAL ULNA PLATE 7H RIGHT TITANIUM 34MM
• 00885556714225: EVOS DISTAL ULNA PLATE 7H LEFT TITANIUM 34MM
• 00885556714218: EVOS DISTAL RADIUS RADIAL COLUMN PLATE 4H RIGHT TITANIUM 57M
• 00885556714201: EVOS DISTAL RADIUS RADIAL COLUMN PLATE 4H LEFT TITANIUM 57MM
• 00885556714195: EVOS DISTAL RADIUS INTERMEDIATE COLUMN PLATE 4H RIGHT TITANI
• 00885556714188: EVOS DISTAL RADIUS INTERMEDIATE COLUMN PLATE 4H LEFT TITANIU
• 00885556714171: EVOS DISTAL RADIUS DORSAL PLATE 3H RIGHT WIDE TITANIUM 58MM
• 00885556714164: EVOS DISTAL RADIUS DORSAL PLATE 3H LEFT WIDE TITANIUM 58MM
• 00885556714157: EVOS DISTAL RADIUS DORSAL PLATE 3H RIGHT STANDARD TITANIUM 5
• 00885556714140: EVOS DISTAL RADIUS DORSAL PLATE 3H LEFT STANDARD TITANIUM 56
• 00885556713990: EVOS 1.8MM X 30MM LOCKING PEG T7
• 00885556713983: EVOS 1.8MM X 28MM LOCKING PEG T7
• 00885556713976: EVOS 1.8MM X 26MM LOCKING PEG T7
• 00885556713969: EVOS 1.8MM X 24MM LOCKING PEG T7
• 00885556713952: EVOS 1.8MM X 23MM LOCKING PEG T7
• 00885556713945: EVOS 1.8MM X 22MM LOCKING PEG T7
• 00885556713938: EVOS 1.8MM X 21MM LOCKING PEG T7
• 00885556713921: EVOS 1.8MM X 20MM LOCKING PEG T7
• 00885556713914: EVOS 1.8MM X 19MM LOCKING PEG T7
• 00885556713907: EVOS 1.8MM X 18MM LOCKING PEG T7
• 00885556713891: EVOS 1.8MM X 17MM LOCKING PEG T7
• 00885556713884: EVOS 1.8MM X 16MM LOCKING PEG T7
• 00885556713877: EVOS 1.8MM X 15MM LOCKING PEG T7
• 00885556713860: EVOS 1.8MM X 14MM LOCKING PEG T7
• 00885556713853: EVOS 1.8MM X 13MM LOCKING PEG T7
• 00885556713846: EVOS 1.8MM X 12MM LOCKING PEG T7
• 00885556713839: EVOS 1.8MM X 11MM LOCKING PEG T7
• 00885556713822: EVOS 1.8MM X 10MM LOCKING PEG T7
• 00885556713815: EVOS 1.8MM X 30MM LOCKING PEG T7
• 00885556713808: EVOS 1.8MM X 28MM LOCKING PEG T7
• 00885556713792: EVOS 1.8MM X 26MM LOCKING PEG T7
• 00885556713785: EVOS 1.8MM X 24MM LOCKING PEG T7
• 00885556713778: EVOS 1.8MM X 23MM LOCKING PEG T7
• 00885556713761: EVOS 1.8MM X 22MM LOCKING PEG T7
• 00885556713754: EVOS 1.8MM X 21MM LOCKING PEG T7
• 00885556713747: EVOS 1.8MM X 20MM LOCKING PEG T7
• 00885556713730: EVOS 1.8MM X 19MM LOCKING PEG T7
• 00885556713723: EVOS 1.8MM X 18MM LOCKING PEG T7
• 00885556713716: EVOS 1.8MM X 17MM LOCKING PEG T7