PECTUS BLU (TM)

Basic Information

• Brand Name: PECTUS BLU (TM)
• Primary DI: 00888233077224
• Version / Model: 78-8300
• Catalog Number: 78-8300
• Company Name: BIOMET MICROFIXATION, INC
• Labeler DUNS: 046189866
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-30
• Public Version: 2
• Public Version Date: 2025-05-30
• Public Version Status: Update
• Public Device Record Key: 8d71f86a-ee1f-4fa2-bc90-d01b2c96aa80

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRS	Plate, fixation, bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61522	Funnel chest remodelling bar	A non-sterile implantable device intended to be used to reduce the deformity of pectus excavatum (funnel chest) by applying outward force from a position deep to the sternum to reposition the sternum; it is typically used in paediatric patients and surgically removed when remodelling is evident (after 2-3 years). It is a thin curved bar, with or without serrations, made of metal [e.g., stainless steel, titanium (Ti)] that can be anchored with wires or with stabilizer plates laterally on the rib cage. This is a single-patient device intended to be sterilized prior to use.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888233077224	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K241709	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			7.62CM (3.00IN)(L)