AccessGUDID - DEVICE: DropSafe Haemolance Plus, safety lancets (05903999602222)

GUDID

Device Identifier (DI) Information

Brand Name: DropSafe Haemolance Plus, safety lancets
Version or Model: 25G x 1.4mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9633
Company Name: HTL STREFA S A

Primary DI Number: 05903999602222
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
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. Intended users are healthcare professionals and lay users.

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?
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: 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: 94e43bb5-b86d-4afe-a339-5d333d6a145a
Public Version Date: January 18, 2024
Public Version Number: 4
DI Record Publish Date: November 08, 2022