Bi-Blade®

Basic Information

• Brand Name: Bi-Blade®
• Primary DI: 00812480011014
• Version / Model: 2370BB
• Catalog Number: 2370BB
• Company Name: MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
• Labeler DUNS: 790265227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-04
• Public Version: 4
• Public Version Date: 2023-05-31
• Public Version Status: Update
• Public Device Record Key: 2ccb864a-7a44-4a76-a1ac-0fbd1f25cc41

Device Description

23 Gauge BB Vitreous Cutter, 20 psi, Luer Anterior PVC Tubing Set, Sterile, Single Use

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	886.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59258	Vitrectomy system micro-cutting unit	A sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10812480011011	GS1	Carton	6	In Commercial Distribution
Primary	00812480011014	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153168	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	23	Gauge

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 98 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 98 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius