FDA.reportPublic FDA data

MCI - Medical Concept Innovation, Inc.

Primary DI
00811687032846
Brand
MCI - Medical Concept Innovation, Inc.
Company
MCI-MEDICAL CONCEPT INNOVATION INC
Model
A02.01.2201
Catalog number
A02.01.2201
Device description
SCREWDRIVER MANIPULATION TIP FOR MEMBRANE
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811687032846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811687032846008116870328468116870328460811687032846

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
954-306-2521customer.service@mci-medical.com

Regulatory Flags#

DUNS number
080815653
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811687032877MCI - Medical Concept Innovation, Inc.A01.01.1137A01.01.11372024-08-27
00811687032884MCI - Medical Concept Innovation, Inc.A01.01.1138A01.01.11382024-08-27
00811687031986MCI - Medical Concept Innovation, Inc.A01.02.1123A01.02.11232024-08-07
00811687031993MCI - Medical Concept Innovation, Inc.A01.02.1011A01.02.10112024-08-07
00811687032006MCI - Medical Concept Innovation, Inc.A01.02.1013A01.02.10132024-08-07
00811687032013MCI - Medical Concept Innovation, Inc.A01.02.1012A01.02.10122024-08-07
00811687032549MCI - Medical Concept Innovation, Inc.A01.01.2310A01.01.23102024-08-07
00811687032556MCI - Medical Concept Innovation, Inc.A01.01.1004A01.01.10042024-08-07
00811687032563MCI - Medical Concept Innovation, Inc.A01.01.3010A01.01.30102024-08-07
00811687032587MCI - Medical Concept Innovation, Inc.A01.02.1101A01.02.11012024-08-07
00811687032594MCI - Medical Concept Innovation, Inc.A01.02.1125A01.02.11252024-08-07
00811687032600MCI - Medical Concept Innovation, Inc.A01.02.1107A01.02.11072024-08-07
00811687032617MCI - Medical Concept Innovation, Inc.A01.02.1110A01.02.11102024-08-07
00811687032624MCI - Medical Concept Innovation, Inc.A01.02.1127A01.02.11272024-08-07
00811687032631MCI - Medical Concept Innovation, Inc.A01.02.1109A01.02.11092024-08-07
00811687032648MCI - Medical Concept Innovation, Inc.A01.02.1103A01.02.11032024-08-07
00811687032655MCI - Medical Concept Innovation, Inc.A01.02.1106A01.02.11062024-08-07
00811687032679MCI - Medical Concept Innovation, Inc.A01.01.4022A01.01.40222024-08-07
00811687032709MCI - Medical Concept Innovation, Inc.A01.01.1153A01.01.11532024-08-07
00811687032747MCI - Medical Concept Innovation, Inc.A01.01.1145A01.01.11452024-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
09120125220228Shark Screw® driversurgebright GmbHHXX2025-09-16
08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24