De Mayo Ankle Distractor™ 1109 SAWBONES

GUDID 00696588003900

1109 Sawbones base & bridge

Innovative Medical Products, Inc

Orthopaedic surgical distractor, external

• Primary Device ID: 00696588003900
• NIH Device Record Key: 670c9649-64e0-433d-b281-566a499913f5
• Commercial Distribution Discontinuation: 2019-11-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: De Mayo Ankle Distractor™
• Version Model Number: 1109 SAWBONES
• Catalog Number: 1109 SAWBONES
• Company DUNS: 147363154
• Company Name: Innovative Medical Products, Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00696588003900 [Primary]

FDA Product Code

• FWZ: Operating Room Accessories Table Tray

Sterilization

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

[00696588003900]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-28
• Device Publish Date: 2019-10-18

On-Brand Devices [De Mayo Ankle Distractor™ ]

• 00696588002439: De Mayo Ankle Distractor™ System (1 ea - 1109, 907 and 713-302)
• 00696588002422: De Mayo Ankle Distractor™ System (1 ea - 1109, 907 and 903)
• 00696588001531: De Mayo Ankle Distractor Accessory (For Posterior Approach)
• 00696588001524: De Mayo Ankle Distractor™ Base & Bridge
• 00696588004099: De Mayo Ankle Distractor™ Sterilization Cases (1 each of 1109-XS and 1109-S)
• 00696588004044: De Mayo Ankle Distractor™ Sterilization Case (907 & Clamp) 14.5" x 10.5" x 6.5"
• 00696588003931: Aluminum Boot Attachment with Pin-Horseshoe Attachment & Pin Holder for De Mayo Ankle Distractor
• 00696588003900: 1109 Sawbones base & bridge
• 00696588001548: De Mayo Ankle Distractor™ Sterilization Case (Base & Bridge) 32" x 12" x 2.5"
• 00696588004730: Loaner De Mayo Ankle Distractor™ Base & Bridge
• 00696588004723: Demo De Mayo Ankle Distractor™ Base & Bridge
• 00696588005348: Demo De Mayo Ankle Distractor™ Sterilization Cases (1 each of 1109-XS and 1109-S)
• 00696588005331: Loaner De Mayo Ankle Distractor™ System (1ea-1109, 907, and 903)
• 00696588006956: De Mayo Ankle Distractor™ System (1 ea - 1109, 907 and 713-717)