Steile Drape for "Cart"

GUDID 04260462743907

sterile Monitor and Boards Drape

Pemax Kunststoff GmbH

Medical equipment/instrument drape, single-use

• Primary Device ID: 04260462743907
• NIH Device Record Key: ac6eea90-3d1f-4c5d-beb0-e6933d335d51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Steile Drape for "Cart"
• Version Model Number: 12935.BUY0887
• Company DUNS: 341672714
• Company Name: Pemax Kunststoff GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de
• Phone: +4974415204900
• Email: info@pemax.de

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260462743907 [Primary]

FDA Product Code

• PUI: Drape, Surgical, Exempt

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: 2025-03-26
• Device Publish Date: 2025-03-18

Devices Manufactured by Pemax Kunststoff GmbH

• 04260462743877 - Sterile Drape for "SCOUT ARM": 2025-03-26 sterile Monitor and Boards Drape
• 04260462743907 - Steile Drape for "Cart": 2025-03-26sterile Monitor and Boards Drape
• 04260462743907 - Steile Drape for "Cart": 2025-03-26 sterile Monitor and Boards Drape
• 04260462743938 - Steile Drape for "Surgical Arm": 2025-03-26 sterile Monitor and Boards Drape
• 04260462743969 - Steile Drape for "CONTROL SCREEN": 2025-03-26 sterile Monitor and Boards Drape
• 04260462740371 - Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mm: 2024-06-13 Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mm
• 04260462740951 - HMD cover set, consisting of 2 lens protective caps made of PP, color white: 2024-06-13 HMD cover set, consisting of 2 lens protective caps made of PP, color white
• 04260462741255 - PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./oran: 2024-06-13 PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./orange line
• 04260462742184 - Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm: 2024-06-13 Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm