DEVICE: StaClear (B994SC250LL0)
Device Identifier (DI) Information
StaClear
SC250LL
In Commercial Distribution
SC250LL
Staclear, Inc.
SC250LL
In Commercial Distribution
SC250LL
Staclear, Inc.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
QLY | Ophthalmic Syringe |
FMF | Syringe, Piston |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K200242 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 0.25 Milliliter |
Device Record Status
2223301b-0c4b-4b7c-9d14-5bcac456ad09
December 15, 2023
3
September 21, 2023
December 15, 2023
3
September 21, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B994SC250LL1 | 25 | B994SC250LL0 | In Commercial Distribution | Box | |
B994SC250LL5 | 10 | B994SC250LL1 | In Commercial Distribution | Case | |
B994SC250LL2 | 50 | B994SC250LL0 | In Commercial Distribution | Convenience Tray | |
B994SC250LL3 | 40 | B994SC250LL0 | In Commercial Distribution | Box | |
B994SC250LL4 | 2 | B994SC250LL2 | In Commercial Distribution | Box | |
B994SC250LL6 | 10 | B994SC250LL3 | In Commercial Distribution | Case | |
B994SC250LL7 | 10 | B994SC250LL4 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
919-838-6716
info@staclear.com
info@staclear.com