3M 70-2011-8758-3

GUDID 00850015378782

Instrument Table Cover 200cmx228cm (90cmx228cm reinf) UDI-DI-159309803EQCJL

EXACT MEDICAL MANUFACTURING, INC.

Medical equipment drape, single-use

• Primary Device ID: 00850015378782
• NIH Device Record Key: 0e606ef7-3018-49c9-af2d-3b67b83d03aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3M
• Version Model Number: 70-2011-8758-3
• Catalog Number: 70-2011-8758-3
• 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	00850015378775 [Primary]
GS1	00850015378782 [Package]; Contains: 00850015378775; Package: Case [384 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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-23
• Device Publish Date: 2020-06-15

On-Brand Devices [3M]

• 00850015378782: Instrument Table Cover 200cmx228cm (90cmx228cm reinf) UDI-DI-159309803EQCJL
• 00850015378768: Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI-159309803EQCJL
• 00850015378744: Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI - 159309803EQCJL
• 00850015378720: Instrument Table Cover 200cmx228cm (90cmx228cm reinf) UDI-DI - 159309803EQCJL
• 00850015378706: Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI-159309803EQCJL
• 00850015378683: Instrument Table Cover 100cmx150cm (76cmx150cm reinf) UDI-DI - 159309803EQCJL
• 06975424194700: Instrument Table Cover 200cmx228cm (90cmx228cm reinf) UDI-DI-159309803EQCJL
• 16975424194691: Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI-159309803EQCJL
• 16975424194684: Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI - 159309803EQCJL
• 16975424194677: Instrument Table Cover 200cmx228cm (90cmx228cm reinf) UDI-DI - 159309803EQCJL
• 16975424194660: Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI-159309803EQCJL
• 16975424194653: Instrument Table Cover 100cmx150cm (76cmx150cm reinf) UDI-DI - 159309803EQCJL