AccessGUDID - DEVICE: Haemolance Plus, safety lancet (05907506237471)

GUDID

Device Identifier (DI) Information

Brand Name: Haemolance Plus, safety lancet
Version or Model: Max Flow, 1.5mm 1.6mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7374
Company Name: HTL STREFA S A

Primary DI Number: 05907506237471
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 422528088 *Terms of Use

Device Description: Safety lancets are sterile, single use medical devices intended for capillary blood sampling.

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":	Yes
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	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
No Device Sizes

Device Record Status

Public Device Record Key: 43d43ceb-e402-4dd1-bb1e-9e1c3eec387b
Public Version Date: June 09, 2020
Public Version Number: 1
DI Record Publish Date: June 01, 2020