E5421 Band Bag with tape 76x86cm - 30"x34" E5421

GUDID 00852205007656

EXACT MEDICAL MANUFACTURING, INC.

Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile Instrument/equipment drape, single-use, sterile

• Primary Device ID: 00852205007656
• NIH Device Record Key: c3587e09-13ea-4587-9c56-a2fadbdb6e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E5421 Band Bag with tape 76x86cm - 30"x34"
• Version Model Number: E5421
• Catalog Number: E5421
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816953021944 [Primary]
GS1	00816953021951 [Package]; Contains: 00816953021944; Package: Case [80 Units]; In Commercial Distribution
GS1	00852205007656 [Package]; Contains: 00816953021944; Package: Inner Case [40 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: 2018-07-06
• Device Publish Date: 2016-10-17

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

• 26975424195237 - Exact Medical Manufacturing: 2024-04-04 Hemorrhage View C-Section Drape, Sterile, Pear Shaped fenestration within incision panel
• 26975424195251 - Exact Medical Manufacturing: 2024-04-04 Hemorrhage View C-Section Drape,Sterile, full incision panel
• 16975424195285 - Exact Medical Manufacturing: 2024-04-04 Foot Switch Cover with drawstring 36x76cm - 14"x30"
• 16975085705526 - Exact Medical: 2024-03-27 Foot Switch Cover, Drawstring and adjuster 56x51cm - 22"x20"
• 16975424194653 - 3M: 2023-12-26 Instrument Table Cover 100cmx150cm (76cmx150cm reinf) UDI-DI - 159309803EQCJL
• 16975424194660 - 3M: 2023-12-26 Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI-159309803EQCJL
• 16975424194677 - 3M: 2023-12-26 Instrument Table Cover 200cmx228cm (90cmx228cm reinf) UDI-DI - 159309803EQCJL
• 16975424194684 - 3M: 2023-12-26 Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI - 159309803EQCJL