FDA.report

PICASSO II

Primary DI
00841732124653
Brand
PICASSO II
Company
CTL MEDICAL CORPORATION
Model
019.7044
Device description
Drill, Cannulated, 1/4" Square QC, D7.0mm
Published
2023-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTWBit, Drill
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841732124653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732124653008417321246538417321246530841732124653

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(214)545-5820schedule@ctlamedica.com

Regulatory Flags

DUNS number
080138504
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841732117860PICASSO II MIS Spinal System119.15352023-09-07
00841732117877PICASSO II MIS Spinal System119.15402023-09-07
00841732117884PICASSO II MIS Spinal System119.15452023-09-07
00841732117891PICASSO II MIS Spinal System119.16352023-09-07
00841732117907PICASSO II MIS Spinal System119.16402023-09-07
00841732117914PICASSO II MIS Spinal System119.16452023-09-07
00841732118959PICASSO II MIS Spinal System119.16502017-08-08
00841732118966PICASSO II MIS Spinal System119.16552017-08-08
00841732118973PICASSO II MIS Spinal System119.16602017-08-08
00841732118980PICASSO II MIS Spinal System119.16652017-08-08
00841732119017PICASSO II MIS Spinal System119.15502017-08-08
00841732119024PICASSO II MIS Spinal System119.15552017-08-08
00841732119031PICASSO II MIS Spinal System119.15602017-08-08
00841732119048PICASSO II MIS Spinal System119.15652017-08-08
00841732119055PICASSO II MIS Spinal System119.15302017-08-08
00841732119062PICASSO II MIS Spinal System119.16302017-08-08
00841732119079PICASSO II MIS Spinal System119.17302017-08-08
00841732168664MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17112026-01-08
00841732168671MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17132026-01-08
00841732168688MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17152026-01-08

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