AccessGUDID - DEVICE: StaClear (B994SC250AN0)

GUDID

Device Identifier (DI) Information

Brand Name: StaClear
Version or Model: SC250AN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SC250AN
Company Name: Staclear, Inc.

Primary DI Number: B994SC250AN0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118961679 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

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Product Code	Product Code Name
QLY	Ophthalmic Syringe
FMF	Syringe, Piston
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.25 Milliliter
Needle Gauge: 31 Gauge
Length: 8 Millimeter

Device Record Status

Public Device Record Key: 713fae02-09dc-4035-90bf-aff1565de875
Public Version Date: April 10, 2025
Public Version Number: 3
DI Record Publish Date: August 16, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B994SC250AN2	20	B994SC250AN0	In Commercial Distribution	Bag
B994SC250AN6	100	B994SC250AN0	In Commercial Distribution	Box
B994SC250AN8	1000	B994SC250AN0	In Commercial Distribution	Case
B994SC250AN4	50	B994SC250AN0	In Commercial Distribution	Convenience Tray