TechLITE Insulin Syringes 0.5mL 31G x 5/16" (8mm)

GUDID 10015482263123

TechLITe Insulin Syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.

ARKRAY USA, INC.

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Primary Device ID	10015482263123
NIH Device Record Key	b8286db9-c92b-43b8-a585-fc324e29aa5a
Commercial Distribution Status	In Commercial Distribution
Brand Name	TechLITE Insulin Syringes 0.5mL 31G x 5/16" (8mm)
Version Model Number	260312
Company DUNS	008171162
Company Name	ARKRAY USA, INC.
Device Count	10
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx
Phone	1-800-818-8877
Email	xxx@xxx.xxx

Device Dimensions

Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge
Total Volume	0.5 Milliliter
Length	8 Millimeter
Needle Gauge	31 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482263126 [Package] Contains: 00015482613129 Package: Carton [10 Units] In Commercial Distribution
GS1	00015482613129 [Primary]
GS1	10015482263123 [Package] Contains: 00015482263126 Package: Master Shipper [10 Units] In Commercial Distribution
GS1	50015482613124 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153537

FDA Product Code

FMF	Syringe, Piston

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2023-07-28
Device Publish Date	2018-01-09

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