D-RAD 71158070

GUDID 00885556631690

D-RAD 1.8MM FIXED ANGLE AND VARIABLE ANGLE DRILL GUIDE

Smith & Nephew, Inc.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable

• Primary Device ID: 00885556631690
• NIH Device Record Key: 993a6e8b-0db0-4fe9-86b1-16d8b3b5968c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-RAD
• Version Model Number: 71158070
• Catalog Number: 71158070
• 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: 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
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556631690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161665

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

[00885556631690]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-12-01

On-Brand Devices [D-RAD]

• 00885556631768: D-RAD PLATE BENDING IRONS
• 00885556631690: D-RAD 1.8MM FIXED ANGLE AND VARIABLE ANGLE DRILL GUIDE
• 00885556631355: D-RAD VOLAR GUIDE BLOCK 5 HOLE RIGHT WIDE
• 00885556631348: D-RAD VOLAR GUIDE BLOCK 5 HOLE AND 10 HOLE RIGHT STANDARD
• 00885556631331: D-RAD VOLAR GUIDE BLOCK 5 HOLE LEFT WIDE
• 00885556631324: D-RAD VOLAR GUIDE BLOCK 5 HOLE AND 10 HOLE LEFT STANDARD
• 00885556631317: D-RAD VOLAR GUIDE BLOCK 3 HOLE AND 4 HOLE RIGHT WIDE
• 00885556631300: D-RAD VOLAR GUIDE BLOCK 3 HOLE AND 4 HOLE RIGHT STANDARD
• 00885556631294: D-RAD VOLAR GUIDE BLOCK 3 HOLE AND 4 HOLE LEFT WIDE
• 00885556631287: D-RAD VOLAR GUIDE BLOCK 3 HOLE AND 4 HOLE LEFT STANDARD
• 00885556630648: D-RAD VOLAR PLATE 10H RIGHT STANDARD TITANIUM
• 00885556630631: D-RAD VOLAR PLATE 10H LEFT STANDARD TITANIUM
• 00885556630624: D-RAD VOLAR PLATE 5H RIGHT WIDE TITANIUM
• 00885556630617: D-RAD VOLAR PLATE 5H RIGHT STANDARD TITANIUM
• 00885556630600: D-RAD VOLAR PLATE 5H LEFT WIDE TITANIUM
• 00885556630594: D-RAD VOLAR PLATE 5H LEFT STANDARD TITANIUM
• 00885556630587: D-RAD VOLAR PLATE 4H RIGHT WIDE TITANIUM
• 00885556630570: D-RAD VOLAR PLATE 4H RIGHT STANDARD TITANIUM
• 00885556630563: D-RAD VOLAR PLATE 4H LEFT WIDE TITANIUM
• 00885556630556: D-RAD VOLAR PLATE 4H LEFT STANDARD TITANIUM
• 00885556630549: D-RAD VOLAR PLATE 3H RIGHT WIDE TITANIUM
• 00885556630532: D-RAD VOLAR PLATE 3H RIGHT STANDARD TITANIUM
• 00885556630525: D-RAD VOLAR PLATE 3H LEFT WIDE TITANIUM
• 00885556630518: D-RAD VOLAR PLATE 3H LEFT STANDARD TITANIUM