FDA.reportPublic FDA data

PICASSO II

Primary DI
00841732117976
Brand
PICASSO II
Company
CTL Medical Corporation
Model
119.7038
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732117976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732117976008417321179768417321179760841732117976

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)545-5820complaints@ctlmed.com

Regulatory Flags#

DUNS number
080138504
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841732144521VALEO II PL OL Interbody Fusion System11.113.45132023-09-22
00841732145474VALEO II PL OL Interbody Fusion System11.113.45092023-09-22
00841732155381VALEO II PL OL Interbody Fusion System11.113.38102023-09-22
00841732155404VALEO II PL OL Interbody Fusion System11.113.38132023-09-22
00841732155411VALEO II PL OL Interbody Fusion System11.113.38142023-09-22
00841732155428VALEO II PL OL Interbody Fusion System11.113.38152023-09-22
00841732155435VALEO II PL OL Interbody Fusion System11.113.45082023-09-22
00841732155442VALEO II PL OL Interbody Fusion System11.113.45102023-09-22
00841732155459VALEO II PL OL Interbody Fusion System11.113.45112023-09-22
00841732155466VALEO II PL OL Interbody Fusion System11.113.45142023-09-22
00841732155923VALEO II PL OL Interbody Fusion System11.113.60072023-09-22
00841732155930VALEO II PL OL Interbody Fusion System11.113.60082023-09-22
00841732155947VALEO II PL OL Interbody Fusion System11.113.60092023-09-22
00841732155954VALEO II PL OL Interbody Fusion System11.113.60102023-09-22
00841732155961VALEO II PL OL Interbody Fusion System11.113.60112023-09-22
00841732155978VALEO II PL OL Interbody Fusion System11.113.60132023-09-22
00841732160200VALEO II PL OL Interbody Fusion System11.113.38112023-09-22
00841732155268VALEO II PL OL Interbody Fusion System11.113.18122023-09-21
00841732155275VALEO II PL OL Interbody Fusion System11.113.18132023-09-21
00841732155299VALEO II PL OL Interbody Fusion System11.113.18152023-09-21

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