Ultilet 30g Classic Twist Lancet

Basic Information

• Brand Name: Ultilet 30g Classic Twist Lancet
• Primary DI: 10743820301014
• Version / Model: 30101
• Company Name: Boca Med, LLC
• Labeler DUNS: 121164730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-02-07
• Public Version: 2
• Public Version Date: 2023-02-22
• Public Version Status: Update
• Public Device Record Key: 8018b127-5bc0-4a7d-bc39-0f29b47c4aa0

Device Description

Ultilet 30g TwistTop Blood Lancet NDC Number: 08326-3010-01

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	878.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45142	Blood lancing device tip	A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10743820301014	GS1
Package	20743820301011	GS1	Inner case	20	In Commercial Distribution
Package	30743820301018	GS1	Master case	10	In Commercial Distribution
Unit of Use	00743820301017	GS1