Colorado Therapeutics Xenograft Implant

Basic Information

• Brand Name: Colorado Therapeutics Xenograft Implant
• Primary DI: 00868623000353
• Version / Model: XI-S+
• Catalog Number: XI0203-S+
• Company Name: COLORADO THERAPEUTICS LLC
• Labeler DUNS: 080356428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-05
• Public Version: 1
• Public Version Date: 2019-03-13
• Public Version Status: New
• Public Device Record Key: d5b8b3cd-ad2c-4947-bf53-6b031e8919ca

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: No
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTM	Mesh, Surgical	General, Plastic Surgery	878.3300	2
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61107	Abdominal hernia surgical mesh, collagen, antimicrobial	A sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it includes a pharmaceutical antibacterial agent. It may also be used as a short-term scaffold for tissue regeneration; it is not designed specifically for diaphragmatic hernia repair and has no extra-abdominal applications. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868623000353	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	2	Centimeter
Length	3	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 35.6 – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 40 Degrees Celsius