StaClear

Primary DI
B994SC2501
Brand
StaClear
Company
Tribofilm Research, 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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QLYOphthalmic Syringe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
B994SC2501PackageHIBCC10In Commercial Distribution
B994SC2502PackageHIBCC20In Commercial Distribution
B994SC2503PackageHIBCC100In Commercial Distribution
B994SC2505PackageHIBCC1000In 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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(919) 838-6716info@tribofilmresearch.com

Regulatory Flags#

DUNS number
115690369
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B994SC250LS2StaClearSC250LS2022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850037925940VitreJect Ophthalmic SyringeOcuject, LLCQLY2025-02-28
00855265008854VitreJect Ophthalmic SyringeOcuject, LLCQLY2025-02-28
00850037925957VitreJect Ophthalmic SyringeOcuject, LLCQLY2025-02-28
00850037925834VitreJect Ophthalmic SyringeOcuject, LLCQLY2025-02-28
B994SC250LL0StaClearStaclear, Inc.QLY2023-09-21
B994SC250AN0StaClearStaclear, Inc.QLY2023-08-16
B994SC250LS0StaClearStaclear, Inc.QLY2022-08-08
B994SC250LS2StaClearTribofilm Research, Inc.QLY2022-08-08
B994SC2500StaClearStaclear, Inc.QLY2020-12-11