AccessGUDID - DEVICE: OneTouch Delica Plus Lancet (00812608030033)

GUDID

Device Identifier (DI) Information

Brand Name: OneTouch Delica Plus Lancet
Version or Model: 013-026
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OTDP Lancet Bag 33g US/CA
Company Name: ASAHI POLYSLIDER COMPANY,LIMITED

Primary DI Number: 00812608030033
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 718296825 *Terms of Use

Device Description: Bag of 10 sterile lancets 33 Gauge

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
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221546	000

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
Needle Gauge: 33 Gauge

Device Record Status

Public Device Record Key: e02413b6-d700-426e-b27a-c90a6cb50e80
Public Version Date: September 28, 2022
Public Version Number: 2
DI Record Publish Date: January 31, 2022