Tesslagra RS1000

GUDID 00850024023383

Axcess Drape - Radial Access Sleeve

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use

• Primary Device ID: 00850024023383
• NIH Device Record Key: d7c563f8-7df2-45b1-bcc7-3e845e54458a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tesslagra
• Version Model Number: RS1000
• Catalog Number: RS1000
• 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	00850024023376 [Primary]
GS1	00850024023383 [Package]; Contains: 00850024023376; Package: CASE [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101688

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: 2021-02-05
• Device Publish Date: 2021-01-28

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

• 16975424195988 - Exact Medical Manufacturing, Inc.: 2025-04-07 General Purpose Probe Cover (3D End), Gel, Bands 6" x 48"
• 16975424195995 - Exact Medical Manufacturing, Inc.: 2025-04-07 C-Arm Drape Miniview 6600/6800, 48 x 84"
• 06975424196001 - Exact Medical Manufacturing, Inc.: 2025-04-07 General Purpose Probe Cover 5" x 48" (13cm x 122cm)
• 16975424196015 - Exact Medical Manufacturing, Inc.: 2025-04-07 Intraoperative Probe Cover w/ Gel 5" x 96" (13cm x 244cm)
• 26975424196067 - Exact Medical Manufacturing, Inc.: 2025-04-07 Microscope Cover Mitaka MM51
• 26975424196074 - Exact Medical Manufacturing, Inc.: 2025-04-07 Microscope Drape For Zeiss OPMI 41" x 80"
• 16975424196084 - Exact Medical Manufacturing, Inc.: 2025-04-07 Microscope Drape- Zeiss MD 112x300cm - 44"x118"
• 26975424196098 - Exact Medical Manufacturing, Inc.: 2025-04-07 Intraoperative Large T-Shaped Probe Cover w/ Gel 6" x 96"