P-K Titanium Motility Peg System

Primary DI
00854066006205
Brand
P-K Titanium Motility Peg System
Company
INTEGRATED ORBITAL IMPLANTS INC
Model
I00087
Published
2015-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQUOcular Peg

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQUOcular PegOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974203000PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEMIntegrated Orbital Implants, Inc.1998-02-04MQU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854066006205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854066006205008540660062058540660062050854066006205

GMDN Terms#

Term, Definition table
TermDefinition
Ocular peg/screw systemAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-424-6537haimplants@ioi.com

Regulatory Flags#

DUNS number
859186348
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854066006236P-K Titanium Motility Peg SystemI000572024-03-15
00854066006052Bio-Eye®I0018C2015-12-01
00854066006069Bio-Eye®I0020C2015-12-01
00854066006076Bio-Eye®I0022C2015-12-01
00854066006083Bio-Eye®I0016P2015-12-01
00854066006090Bio-Eye®I0018P2015-12-01
00854066006106Bio-Eye®I0020P2015-12-01
00854066006113Bio-Eye®I0022P2015-12-01
00854066006120Bio-Eye®I0024P2015-12-01
00854066006007Bio-Eye®I00016S2015-12-01
00854066006014Bio-Eye®I00018S2015-12-01
00854066006021Bio-Eye®I00020S2015-12-01
00854066006038Bio-Eye®I00022S2015-12-01
00854066006045Bio-Eye®I00024S2015-12-01
00854066006168P-K Titanium Motility Peg SystemI000452015-12-01
00854066006175P-K Titanium Motility Peg SystemI001002015-12-01
00854066006182P-K Titanium Motility Peg SystemI000492015-12-01
00854066006199P-K Titanium Motility Peg SystemI000512015-12-01
00854066006212P-K Titanium Motility Peg SystemI000892015-12-01
00854066006137NAI000412015-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854066006168P-K Titanium Motility Peg SystemINTEGRATED ORBITAL IMPLANTS INCMQU2015-12-01
00854066006175P-K Titanium Motility Peg SystemINTEGRATED ORBITAL IMPLANTS INCMQU2015-12-01
00854066006182P-K Titanium Motility Peg SystemINTEGRATED ORBITAL IMPLANTS INCMQU2015-12-01
00854066006199P-K Titanium Motility Peg SystemINTEGRATED ORBITAL IMPLANTS INCMQU2015-12-01
00854066006212P-K Titanium Motility Peg SystemINTEGRATED ORBITAL IMPLANTS INCMQU2015-12-01