AccessGUDID - DEVICE: StaClear (B994SC2500)

GUDID

Device Identifier (DI) Information

Brand Name: StaClear
Version or Model: SC250
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SC250
Company Name: Staclear, Inc.

Primary DI Number: B994SC2500
Issuing Agency: HIBCC
Commercial Distribution End Date: September 01, 2023
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

[?]

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

[?]

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 [?]
K200242	000

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: 2b3b5703-559a-4ff2-bc02-70f52081f335
Public Version Date: December 15, 2023
Public Version Number: 5
DI Record Publish Date: December 11, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B994SC2501	10	B994SC2500	2023-08-16	Not in Commercial Distribution	bag
B994SC2503	100	B994SC2500	2023-09-01	Not in Commercial Distribution	box
B994SC2505	1000	B994SC2500	2023-09-01	Not in Commercial Distribution	case
B994SC2502	20	B994SC2500	2023-09-01	Not in Commercial Distribution	bag