FDA.reportPublic FDA data

StaClear

Primary DI
B994SC2500
Brand
StaClear
Company
Staclear, Inc.
Model
SC250
Catalog number
SC250
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.
Published
2020-12-11
Public version status
Update
Distribution status
Not 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
FMINeedle, Hypodermic, Single Lumen
QLYOphthalmic Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral 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
B994SC2501PackageHIBCC10Not in Commercial Distribution
B994SC2502PackageHIBCC20Not in Commercial Distribution
B994SC2503PackageHIBCC100Not in Commercial Distribution
B994SC2505PackageHIBCC1000Not in Commercial Distribution
B994SC2500PrimaryHIBCC0

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
Length8Millimeter
Needle Gauge31Gauge
Total Volume0.25Milliliter

Contacts#

Phone, Email table
PhoneEmail
(919) 838-6716info@tribofilmresearch.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
B994SC250LL0StaClearSC250LLSC250LL2023-09-21
B994SC250AN0StaClearSC250ANSC250AN2023-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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