FDA.report

TUBULAR Access

Primary DI
00841732117488
Brand
TUBULAR Access
Company
CTL MEDICAL CORPORATION
Model
060.7321
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
GDIDissector, Surgical, General & Plastic Surgery
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841732117488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732117488008417321174888417321174880841732117488

GMDN Terms

TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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

Other Devices From This Company

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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
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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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