StaClear

Basic Information

• Brand Name: StaClear
• Primary DI: B994SC2500
• Version / Model: SC250
• Catalog Number: SC250
• Company Name: Staclear, Inc.
• Labeler DUNS: 118961679
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-11
• Public Version: 5
• Public Version Date: 2023-12-15
• Public Version Status: Update
• Public Device Record Key: 2b3b5703-559a-4ff2-bc02-70f52081f335
• Distribution End Date: 2023-09-01

Device Description

The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger gasket, needle, needle cap, and plunger cap. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear® Syringe is suitable for ophthalmic 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: 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
QLY	Ophthalmic Syringe	General Hospital	880.5860	2
FMF	Syringe, Piston	General Hospital	880.5860	2
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63095	General-purpose syringe/needle	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B994SC2501	HIBCC	bag	10	Not in Commercial Distribution	2023-08-16
Primary	B994SC2500	HIBCC
Package	B994SC2503	HIBCC	box	100	Not in Commercial Distribution	2023-09-01
Package	B994SC2505	HIBCC	case	1000	Not in Commercial Distribution	2023-09-01
Package	B994SC2502	HIBCC	bag	20	Not in Commercial Distribution	2023-09-01

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K200242	000

Device Sizes

Type	Value	Unit	Text
Total Volume	0.25	Milliliter
Needle Gauge	31	Gauge
Length	8	Millimeter