Surgical Instruments CSA92501

GUDID 00885556859988

RETRACTOR BASE

Smith & Nephew, Inc.

Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis

• Primary Device ID: 00885556859988
• NIH Device Record Key: 9f184343-fbe4-4886-afa0-7956f74b5228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Instruments
• Version Model Number: CSA-925-01
• Catalog Number: CSA92501
• 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
• 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	00885556859988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151459

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

[00885556859988]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-17

On-Brand Devices [Surgical Instruments]

• 00885556864197: RSS DRILL DEPTH GAUGE
• 00885556862247: 1/8 HEX DRIVER
• 00885556862186: SLAP HAMMER
• 00885556861691: GLENOID RETRACTOR S
• 00885556861684: GLENOID RETRACTOR L
• 00885556861677: HOHMAN RETRACTOR
• 00885556861660: DARRACH RETRACTOR 11S
• 00885556861653: DARRACH RETRACTOR 11L
• 00885556856635: CASE LID
• 00885556856499: PIP ALIGNMENT AWL
• 00885556856475: ALIGNMENT GUIDE. E/M
• 00885556854747: GENERIC CASE LID HALF SIZE
• 00885556834985: FORCEPS. SCREW HOLDING
• 00885556830970: KOLBEL RETRACTOR FRAME
• 00885556830963: FUKUDA RETRACTOR SMALL
• 00885556830925: HOHMAN RETRACTOR
• 00885556830918: DELTOID RETRACTOR
• 00885556830833: SIZING TEMPLATE. PHS SZ. 50
• 00885556830826: SIZING TEMPLATE. PHS SZ. 40
• 00885556830819: SIZING TEMPLATE. PHS SZ. 30
• 00885556830802: SIZING TEMPLATE. PHS SZ. 20
• 00885556830796: SIZING TEMPLATE. PHS SZ. 10
• 00885556829967: 2.4MM PROVISIONAL FIXATION PIN
• 00885556829950: DRILL GUIDE DEPTH GAUGE
• 00885556829943: PLATE DEPTH GAUGE
• 00885556829936: 2.4MM LOCKING DRILL GUIDE
• 00885556829752: 3.5MM DIA DRILL WITH AO CONNECTION
• 00885556829745: 2.4MM DIA X 80MM DEPTH DRILL WITH AO CONNECTION
• 00885556829738: 1.9MM DIA X 50MM DEPTH DRILL WITH AO CONNECTION
• 00885556829721: 3.5MM DRILL GUIDE
• 00885556829714: 3.5MM SCREW GUIDE
• 00885556829707: 2.4MM DRILL GUIDE
• 00885556829646: PERIOSTEAL ELEVATOR
• 00885556829639: TORX 8 DRIVE SHAFT
• 00885556829622: TORX 15 DRIVE SHAFT
• 00885556829615: BONE REDUCTION FCPS STR 9IN
• 00885556829608: BONE REDUCTION FORCEPS CURVED 8IN
• 00885556829592: AO TO TRINKLE ADAPTER
• 00885556859988: RETRACTOR BASE
• 00885556863664: 2.8MM DRILL BIT FOR 5.5 SCREWS
• 00885556863657: 2.5 DRILL BIT FOR 4.5 SCREWS
• 00885556861721: KOLBEL RETRACTOR BLADE X-LARGE
• 00885556861714: KOLBEL RETRACTOR BLADE SMALL
• 00885556861707: KOLBEL RETRACTOR BLADE LARGE
• 00885556861523: T-HANDLE. FIXED. NO CANNULATION. BLUE
• 00885556860274: TORQUE LIMITER
• 00885556859193: PIN PULLER
• 00885556857328: IMPLANT IMPACTOR
• 00885556856680: EXTRACTOR
• 00885556856628: CUP AND CONE REAMER LID (CADDY)