AccessGUDID - DEVICE: SensiLance-Button Activated Safety Lancets (00616784712529)

GUDID

Device Identifier (DI) Information

Brand Name: SensiLance-Button Activated Safety Lancets
Version or Model: 7125
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784712529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: SensiLance, Button Activated Safety Lancets, Sterile, 28 Gauge Needle, 1.8mm Depth Setting

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
61579	Blood lancet, single-use	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: 6eb75c1e-82e5-4d08-bb1a-b0cb383805b9
Public Version Date: October 09, 2024
Public Version Number: 3
DI Record Publish Date: May 04, 2022