FDA.report

TUBULAR Access

Primary DI
00841732117136
Brand
TUBULAR Access
Company
CTL MEDICAL CORPORATION
Model
060.6020
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GADRetractor
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841732117136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732117136008417321171368417321171360841732117136

GMDN Terms

TermDefinition
Suction cannula, reusableA rigid or semi-rigid, hand-held, metal or durable plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open-, plastic-, tissue/bone morcellation surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(214)545-5820complaints@ctlmed.com
+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

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00841732117884PICASSO II MIS Spinal System119.15452023-09-07
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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
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