Proximal Humeral Fracture Plate System PSS-3540LS

GUDID 00885556830253

3.5MM LOCKING SCREW STAINLESS STEEL 40MM

Smith & Nephew, Inc.

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• Primary Device ID: 00885556830253
• NIH Device Record Key: 3e98ced4-c50a-4af1-afc6-0d076e5a9730
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proximal Humeral Fracture Plate System
• Version Model Number: PSS-3540LS
• Catalog Number: PSS-3540LS
• Company DUNS: 045483575
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556830253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121826

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

[00885556830253]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2022-12-22

On-Brand Devices [Proximal Humeral Fracture Plate System]

• 00885556829912: GREATER TUBEROSITY HUMERAL FRACTURE PLATE TARGET
• 00885556829899: LOW PROFILE HUMERAL FRACTURE PLATE TARGET GUIDE.
• 00885556829905: GREATER TUBEROSITY HUMERAL FRACTURE PLATE TARGET
• 00885556829882: LOW PROFILE HUMERAL FRACTURE PLATE TARGET GUIDE.
• 00885556829929: 1.9MM LOCKING DRILL GUIDE
• 00885556830406: 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 75MM
• 00885556830390: 3.5MM LOCKING SCREW STAINLESS STEEL 75MM
• 00885556830383: 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 70MM
• 00885556830376: 3.5MM LOCKING SCREW STAINLESS STEEL 70MM
• 00885556830369: 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 65MM
• 00885556830352: 3.5MM LOCKING SCREW STAINLESS STEEL 65MM
• 00885556830345: 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 60MM
• 00885556830338: 3.5MM LOCKING SCREW STAINLESS STEEL 60MM
• 00885556830321: 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 55MM
• 00885556830314: 3.5MM LOCKING SCREW STAINLESS STEEL 55MM
• 00885556830307: 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 50MM
• 00885556830291: 3.5MM LOCKING SCREW STAINLESS STEEL 50MM
• 00885556830284: 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 45MM
• 00885556830277: 3.5MM LOCKING SCREW STAINLESS STEEL 45MM
• 00885556830260: 3.5MM COMPRESSION SCREW PARTIAL THREAD SS 40MM
• 00885556830253: 3.5MM LOCKING SCREW STAINLESS STEEL 40MM
• 00885556830246: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 40MM
• 00885556830239: 3.5MM LOCKING SCREW STAINLESS STEEL 37.5MM
• 00885556830222: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 37.5MM
• 00885556830215: 3.5MM LOCKING SCREW STAINLESS STEEL 35MM
• 00885556830208: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 35MM
• 00885556830192: 3.5MM LOCKING SCREW STAINLESS STEEL 32.5MM
• 00885556830185: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 32.5MM
• 00885556830178: 3.5MM LOCKING SCREW STAINLESS STEEL 30MM
• 00885556830161: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 30MM
• 00885556830154: 3.5MM LOCKING SCREW STAINLESS STEEL 27.5MM
• 00885556830147: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 27.5MM
• 00885556830130: 3.5MM LOCKING SCREW STAINLESS STEEL 25MM
• 00885556830123: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 25MM
• 00885556830116: 3.5MM LOCKING SCREW STAINLESS STEEL 22.5MM
• 00885556830109: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 22.5MM
• 00885556830093: 3.5MM LOCKING SCREW STAINLESS STEEL 20MM
• 00885556830086: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 20MM
• 00885556830079: 3.5MM LOCKING SCREW STAINLESS STEEL 17.5MM
• 00885556830062: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 17.5MM
• 00885556830055: 3.5MM LOCKING SCREW STAINLESS STEEL 15MM
• 00885556830048: 3.5MM COMPRESSION SCREW FULL THREAD STAINLESS STEEL 15MM
• 00885556830031: 2.7MM LOCKING SCREW SS 25MM
• 00885556830024: 2.7MM LOCKING SCREW SS 22.5MM
• 00885556830017: 2.7MM LOCKING SCREW SS 20MM
• 00885556830000: 2.7MM LOCKING SCREW SS 17.5MM
• 00885556829998: 2.7MM LOCKING SCREW SS 15MM
• 00885556829981: 2.7MM LOCKING SCREW SS 12.5MM
• 00885556829974: 2.7MM LOCKING SCREW SS 10MM
• 00885556829875: GREATER TUBEROSITY HUMERAL FRACTURE PLATE 10-HOLE. RIGHT