Aesculap PE485A

GUDID 04250325493759

Aesculap Full-HD Arthroscope, 0°, 4,0mm

Vitalitec International Medizintechnik GmbH

Rigid arthroscope, reusable

• Primary Device ID: 04250325493759
• NIH Device Record Key: a3c3b541-0547-4b53-917c-4cce789f2691
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aesculap
• Version Model Number: PE485A
• Catalog Number: PE485A
• Company DUNS: 328485453
• Company Name: Vitalitec International Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250325493759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942730

FDA Product Code

• HET: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-10
• Device Publish Date: 2019-07-02

Devices Manufactured by Vitalitec International Medizintechnik GmbH

• 04250325496699 - Vitalitec: 2024-11-06 QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP,1,5 mm, 8" -for cervical use only
• 04250325496859 - Vitalitec: 2024-11-06 QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP,2,5 mm, 8"
• 04250325496774 - Vitalitec: 2024-10-29 QUICK RELEASE Micro Kerrison Rongeur, Rongeur, thin footplate, 12 mm bite open 40d UP, 1mm, 8" - for cervical use only
• 04250325496910 - Vitalitec: 2024-10-29 QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP, 2mm, 8" - for cervical use only
• 04250325497047 - Vitalitec: 2024-10-29 QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP, 3mm, 8"
• 04250325497160 - Vitalitec: 2024-10-29 QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP, 4mm, 8"
• 04250325497306 - Vitalitec: 2024-10-29 QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP, 5mm, 8"
• 04250325411692 - Vitalitec: 2024-03-12 Endoscopic Applier, 10 mm, 33 cm rotatable and dismantable for SLS medium-large clips