Coulmed DI-1406A

GUDID 00850024023987

Coulmed Double Back Table Cover 72" Wide

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850024023987
• NIH Device Record Key: 7c897817-8d30-4762-970d-4ed5f1100d16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coulmed
• Version Model Number: DI-1406A
• Catalog Number: DI-1406A
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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	00850003355320 [Primary]
GS1	00850024023987 [Package]; Contains: 00850003355320; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-04-29
• Device Publish Date: 2019-05-28

On-Brand Devices [Coulmed]

• 00850003355290: Half-Bag C-Arm Cover 36”x80”
• 00850003355351: Coulmed C-Sheet Standard 137x81cm- 54"x32"
• 00850003355337: Coulmed Double Back Table Cover 72" Wide
• 00850003355313: Coulmed C-Arm Kit XXIII (equipment covers only)
• 00850024023987: Coulmed Double Back Table Cover 72" Wide
• 00850024023949: Double Back Table Cover 6'
• 00850024023925: Double Back Table Cover 5'
• 00850024023901: Double Back Table Cover 4'
• 00850031271050: Microscope Drape- Zeiss MD 117x305cm
• 00850031271197: Microscope Drape- Zeiss MD, 137x381cm - 54"x150"
• 00850031271173: Microscope Drape- Zeiss MD 117x267cm
• 00850031271159: Microscope Drape, Leica, Bayonet, 137x381cm -54x150"
• 00850031271135: Microscope Drape, Leica, Bayonet, 137x305cm - 54"x120"
• 00850031271111: Microscope Drape- Leica 117x305cm- 46x120"