Model: 30GI
DI: 00860015786838
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
RightLance Blood Lancing System (Lancet)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8aa81c40-4c15-4794-8ecf-7b90beaa8894
Distribution Status:
In Commercial Distribution
DUNS Number:
117033737
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860015786838
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61579
Name: Blood lancet, single-use
Definition:
A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.
FDA Product Codes
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Premarket Submissions
Submission Number:
K222034
Supplement Number:
000