AccessGUDID - DEVICE: Orbital Implant Inserter (05060171621850)

GUDID

Device Identifier (DI) Information

Brand Name: Orbital Implant Inserter
Version or Model: INSTR01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CERAMISYS LTD

Primary DI Number: 05060171621850
Issuing Agency: GS1
Commercial Distribution End Date: October 20, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 423459374 *Terms of Use

Device Description: Orbital Implant Inserter

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?
32766	Orbital sphere implant introducer	A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNP	Introducer, Sphere

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: 180e6e1c-6e10-4286-835b-c7cd0af09d71
Public Version Date: October 21, 2021
Public Version Number: 3
DI Record Publish Date: July 31, 2015