Medtronics 9736245

GUDID 10850003355549

Sterile Drapes 9736245 Autoguide 15pk / Sterile Drapes Autoguide 15 pack, Inner case 10850003355549 - Sterile Drapes 9736245 Autoguide 15pk / Sterile Drapes Autoguide 15 pack,Outer case 00850003355535 - DRAPE 29694 STERILE CU STEALTH AUTOGUIDE / Control Unit Drape, PE with Elastic Bands 25cm x 100cm - 9.8"x39.4", 15 each 00850003355528 - DRAPE 31304 STERILE TU STEALTH AUTOGUIDE / Targeting Unit Drape, PE adapters 50cm x 100cm - 19"x39.4", 15 each

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use, sterile

• Primary Device ID: 10850003355549
• NIH Device Record Key: 3b9bba17-4920-47ad-a3d2-de5f9f756244
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronics
• Version Model Number: 9736245
• Catalog Number: 9736245
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003355542 [Primary]
GS1	10850003355549 [Package]; Contains: 00850003355542; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101598

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-11-14

On-Brand Devices [Medtronics]

• 10850003355549: Sterile Drapes 9736245 Autoguide 15pk / Sterile Drapes Autoguide 15 pack, Inner case 1085000335
• 00850003355535: DRAPE 29694 STERILE CU STEALTH AUTOGUIDE
• 00850003355528: DRAPE 31304 STERILE TU STEALTH AUTOGUIDE