Mr. Clear Purple

Basic Information

• Brand Name: Mr. Clear Purple
• Primary DI: 00817984011126
• Version / Model: 0600-AF031-GER-000
• Catalog Number: 0600-AF031-GER-000
• Company Name: MECTRA LABS, INC.
• Labeler DUNS: 606939072
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-24
• Public Version: 2
• Public Version Date: 2020-01-13
• Public Version Status: Update
• Public Device Record Key: 2644b11a-c71c-4b43-8311-dcc9a2b4ec75
• Distribution End Date: 2020-01-10

Device Description

Mr. Clear Purple Foam Pad

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCT	Anti fog solution and accessories, endoscopy	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12291	Rigid optical laparoscope	An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817984011123	GS1	Inner Pack	20	Not in Commercial Distribution	2020-01-10
Primary	00817984011126	GS1
Package	20817984011120	GS1	Case	25	Not in Commercial Distribution	2020-01-10

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 115 Degrees Fahrenheit