FDA.reportPublic FDA data

GENERIC Surgical Instruments

Primary DI
00841732108028
Brand
GENERIC Surgical Instruments
Company
CTL Medical Corporation
Model
015.7069
Device description
Rod Pusher
Published
2016-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00841732108028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732108028008417321080288417321080280841732108028

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. 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
+1(214)545-5820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
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
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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