AccessGUDID - DEVICE: Orabloc - needle stick safety system (08051040583000)

GUDID

Device Identifier (DI) Information

Brand Name: Orabloc - needle stick safety system
Version or Model: 20200707
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20200707
Company Name: PIERREL SPA

Primary DI Number: 08051040583000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 458463044 *Terms of Use

Device Description: The Needlestick Safety system is designed for safely recapping needles. The device consists of a disk, filled with 100 micro rubber caps, suitable for recapping needles after utilisation, for a safe disposal.

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?
36187	Needle recapping device, single-use	A device intended to hold a needle cap and allow a user to conveniently recap a needle, providing some user protection against needle sticks. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, Hypodermic, Single Lumen

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dry place at +5°C(41°F) to +40°C(104°F)

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 capsules that fit a range of needle sizes

Device Record Status

Public Device Record Key: b4fed59d-8f88-489f-82bc-50b277d98bc4
Public Version Date: June 23, 2023
Public Version Number: 2
DI Record Publish Date: October 30, 2020