AccessGUDID - DEVICE: Replacement SS attachments for Durette® IV (set of 4) (20697660002495)

GUDID

Device Identifier (DI) Information

Brand Name: Replacement SS attachments for Durette® IV (set of 4)
Version or Model: 21-550
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Oculo-Plastik Inc

Primary DI Number: 20697660002495
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 257382580 *Terms of Use

Device Description: Replacement stainless-steel attachments for Durette IV (set of 4)

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
64273	Epiocular radiation shield, reusable	An opaque ocular covering intended to be used to shield the entire eye area of a patient or healthcare personnel from exposure to primary and scattered radiation (ionizing and/or non-ionizing) during a medical procedure [e.g., CT scan, dermatological laser treatment, phototherapy]. It is made of materials that prevent the transmission of harmful radiation to the eyes (e.g., lead, tungsten, plastic), and is typically in the form of a single or double opaque shield adhered to the face in front of the eyes (i.e. not directly on the corneal surface); it is not designed as goggles or spectacles. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWS	Shield, Eye, Radiological

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 5217ce1f-cf25-4103-9160-bcea1c5fefc5
Public Version Date: November 19, 2019
Public Version Number: 1
DI Record Publish Date: November 11, 2019