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.

• 16975424198729 - Proficient Surgical: 2026-03-19 INTRAOPERATIVE PROBE DRAPE, 5” X 96"
• 16975424198736 - Proficient Surgical: 2026-03-19 DELUXE VIDEO CAMERA DRAPE, 7” X 96"
• 26975424198832 - Exact Medical Manufacturing, Inc.: 2026-03-17 Sterile Covers for VPS G4 Console
• 16975424199276 - Exact Medical Manufacturing, Inc.: 2026-03-17 Cover for Xray Screen 160x160cm
• 26975424198443 - Exact Medical Manufacturing, Inc.: 2026-03-13 UNIVERSAL GAMMA PROBE CVR 1.25in. x 12in. (3cm x30.5cm)
• 26975424198450 - Exact Medical Manufacturing, Inc.: 2026-03-13 ANGLED WIRELESS GAMMA PROBE CVR 1.25in.x10.25in.(3cm x 26cm)
• 26975424198467 - Exact Medical Manufacturing, Inc.: 2026-03-13 UNIVERSAL GAMMA PROBE COVER 5in. x 96in. (13cm x 244cm)
• 16975424196206 - Exact Medical Manufacturing, Inc.: 2026-01-13 Robot Arm Sterile Drape