StaClear

Primary DI
B994SC250LL0
Brand
StaClear
Company
Staclear, Inc.
Model
SC250LL
Catalog number
SC250LL
Device description
The StaClear Model SC250LL Syringe is a single-use piston syringe consisting of a graduated barrel with luer lock connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Model SC250LL Syringe is suitable for ophthalmic use.
Published
2023-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
QLYOphthalmic Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
QLYOphthalmic SyringeGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200242000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200242000StaClear SyringeTribofilm Research, Inc.2020-07-27QLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B994SC250LL1PackageHIBCC25In Commercial Distribution
B994SC250LL2PackageHIBCC40In Commercial Distribution
B994SC250LL3PackageHIBCC40In Commercial Distribution
B994SC250LL4PackageHIBCC2In Commercial Distribution
B994SC250LL5PackageHIBCC250In Commercial Distribution
B994SC250LL6PackageHIBCC10In Commercial Distribution
B994SC250LL7PackageHIBCC10In Commercial Distribution
B994SC250LL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.25Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
919-838-6716info@staclear.com

Regulatory Flags#

DUNS number
118961679
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B994SC250LS0StaClearSC250LS2022-08-08
B994SC250AN0StaClearSC250ANSC250AN2023-08-16
B994SC2500StaClearSC250SC2502020-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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