FDA.report

GENERIC

Primary DI
00841732123786
Brand
GENERIC
Company
CTL Medical Corporation
Model
100.7054
Device description
K-Wire, Threaded Trocar Tip, L560mm, D1.4, Nitinol
Published
2025-06-02
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
FZXGuide, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841732123786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732123786008417321237868417321237860841732123786

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. 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
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
00841732168695MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17172026-01-08
00841732168701MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17192026-01-08
00841732168718MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17512026-01-08
00841732168725MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17532026-01-08
00841732168732MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17552026-01-08
00841732168749MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17572026-01-08
00841732168756MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17592026-01-08
00841732168763MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19132026-01-08
00841732168770MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19152026-01-08
00841732168787MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19172026-01-08
00841732168794MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19192026-01-08
00841732168800MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19532026-01-08
00841732168817MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19552026-01-08
00841732168824MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19572026-01-08
00841732168831MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19592026-01-08
00841732167483Generic100.77552024-12-10
00841732167490Generic100.77652024-12-10

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09421038411940Dist Fem Cut Block Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411964Dist Fem Cut Block Slot Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411971Dist Fem Cut Block Slot Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411988Dist Fem Cut Block – 1.27mmENZTEC LIMITEDFZX2026-02-27
09421038411995IM Rod – 8mm x 135mmENZTEC LIMITEDFZX2026-02-27