AccessGUDID - DEVICE: Sterilance Soft Lancet 26G (16945630123075)

GUDID

Device Identifier (DI) Information

Brand Name: Sterilance Soft Lancet 26G
Version or Model: 01-0126
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sterilance Medical (Suzhou) Inc.

Primary DI Number: 16945630123075
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 554434897 *Terms of Use

Device Description: No description.

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):	Yes
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
QQK	Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

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: 076d08bc-cd4d-4932-a05b-f0e0d29d548a
Public Version Date: January 23, 2024
Public Version Number: 1
DI Record Publish Date: January 15, 2024