AccessGUDID - DEVICE: DropSafe® Insulin Safety Syringe with Fixed Needle (85903999600774)

GUDID

Device Identifier (DI) Information

Brand Name: DropSafe® Insulin Safety Syringe with Fixed Needle
Version or Model: 0.5ml 31G x 6mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6081
Company Name: HTL STREFA S A

Primary DI Number: 85903999600774
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 422528088 *Terms of Use

Device Description: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safety shield to cover the needle. This device is intended for the delivery of U-100 insulin.

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?
34973	Insulin syringe/needle, safety	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEG	Syringe, Antistick

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132681	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
No Device Sizes

Device Record Status

Public Device Record Key: f27e048f-9d44-4261-85f3-92ae99e3c5b5
Public Version Date: December 22, 2021
Public Version Number: 1
DI Record Publish Date: December 10, 2021