AccessGUDID - DEVICE: P-K Titanium Motility Peg System (00854066006212)

GUDID

Device Identifier (DI) Information

Brand Name: P-K Titanium Motility Peg System
Version or Model: I00089
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTEGRATED ORBITAL IMPLANTS INC

Primary DI Number: 00854066006212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 859186348 *Terms of Use

Device Description: No description.

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?
44420	Ocular peg/screw system	An assembly of devices used together with certain types of ocular rim prostheses for patients who wish to gain improved prosthetic eye motility by coupling the ocular implant to the prosthetic eye. This device will typically consist of screws made of, e.g., titanium (Ti)/stainless steel, or pegs made of, e.g., polyethylene (PE), and small magnets; included may be the tools (e.g., a screwdriver, a holding clamp, and drill bits) necessary for insertion of the screws/magnets. The magnets are embedded into the posterior of the prosthetic eye and powerful enough to provide a coupling force between the implant and the prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQU	Ocular Peg

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974203	000

Device Exempt from Premarket Submission: No 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: 37bac3b3-2030-431c-8a2a-7e778e3895b4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 01, 2015