FDA.reportPublic FDA data

P-K Titanium Motility Peg System

Primary DI
00854066006236
Brand
P-K Titanium Motility Peg System
Company
INTEGRATED ORBITAL IMPLANTS INC
Model
I00057
Device description
Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded Sleeve/Flat Peg (I00100). Manual, single-use, nonsterile surgical instrument.
Published
2024-03-15
Public version status
New
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
LRZScrewdriver, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854066006236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854066006236008540660062368540660062360854066006236

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(858) 677-9990haimplants@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
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
00854066006205P-K Titanium Motility Peg SystemI000872015-12-01
00854066006212P-K Titanium Motility Peg SystemI000892015-12-01
00854066006137NAI000412015-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731137951TITANEX VILEX LLCLRZ2026-05-15
00841731137968TITANEX VILEX LLCLRZ2026-05-15
00841731138149TITANEX VILEX LLCLRZ2026-05-15
00841731140784TITANEX VILEX LLCLRZ2026-05-15
00841731141927TITANEX VILEX LLCLRZ2026-05-15
00841731146816TITANEX VILEX LLCLRZ2026-05-15
00841731146823TITANEX VILEX LLCLRZ2026-05-15
00841731146830TITANEX VILEX LLCLRZ2026-05-15
00841731146847TITANEX VILEX LLCLRZ2026-05-15
00841731152237DYNEX VILEX LLCLRZ2026-05-15
00841731152121DYNEX VILEX LLCLRZ2026-05-11
00841731152183DYNEX VILEX LLCLRZ2026-05-11
00841731152282DYNEX VILEX LLCLRZ2026-05-11
08800016101362Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114447Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114454Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114461Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114478Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114485Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115024Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115840Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115857Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016116014Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016144772Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163087Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163094Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176742Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176759Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176766Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176773Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28