AccessGUDID - DEVICE: TechLITE® Lancets (00015482880125)

GUDID

Device Identifier (DI) Information

Brand Name: TechLITE® Lancets
Version or Model: 880125
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ARKRAY USA, INC.

Primary DI Number: 00015482880125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 008171162 *Terms of Use

Device Description: TechLITE Lancets 25g 100's. Load lancet into lancing device and twist off protective cap. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container. (Primary UPC# 015482880125; Shipper UPC# 015482882549 are used as the assigned UDI for the Class I device.)

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):	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMK	Lancet, Blood

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Needle Gauge: 25 Gauge

Device Record Status

Public Device Record Key: c52e624d-45fe-424f-81b1-7dbee614abe1
Public Version Date: October 25, 2018
Public Version Number: 1
DI Record Publish Date: September 24, 2018