E2341N Radial Femoral Drape 330x260cm E2341N

GUDID 00816953020671

EXACT MEDICAL MANUFACTURING, INC.

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• Primary Device ID: 00816953020671
• NIH Device Record Key: 5766402f-bff0-430b-9585-b7939deeee11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E2341N Radial Femoral Drape 330x260cm
• Version Model Number: E2341N
• Catalog Number: E2341N
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com
• Phone: 716-681-0866
• Email: rdean@exactmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816953020664 [Primary]
GS1	00816953020671 [Package]; Contains: 00816953020664; Package: Case [156 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: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-10-10

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• 16975424194660 - 3M: 2023-12-26 Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI-159309803EQCJL
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