FDA.reportPublic FDA data

Titanium Castroviejo Straight Needle Holder, With Lock, Suture Cutting

Primary DI
00840096206647
Brand
Titanium Castroviejo Straight Needle Holder, With Lock, Suture Cutting
Company
KATALYST SURGICAL LLC
Model
5004SS-140L-SC
Device description
Titanium Castroviejo Straight Needle Holder, With Lock, Suture Cutting
Published
2020-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GDFGuide, Needle, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096206647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096206647008400962066478400962066470840096206647

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007883297
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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10817489024833Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5DKIF7-05S2017-03-22
10817489024840Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 5DKIF7-10S2017-03-22
10817489024857Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5DKIF7-15S2017-03-22
10817489024864Disposable Bipolar Focused Irrigating Forceps, 8", 0.5mm Straight Tips, Box of 5DKIF8-05S2017-03-22
10817489024871Disposable Bipolar Focused Irrigating Forceps, 8", 1.0mm Straight Tips, Box of 5DKIF8-10S2017-03-22
10817489024888Disposable Bipolar Focused Irrigating Forceps, 8", 1.5mm Straight Tips, Box of 5DKIF8-15S2017-03-22
10817489024895Disposable Bipolar Focused Irrigating Forceps, 9", 0.5mm Straight Tips, Box of 5DKIF9-05S2017-03-22
10817489024901Disposable Bipolar Focused Irrigating Forceps, 9", 1.0mm Straight Tips, Box of 5DKIF9-10S2017-03-22
10817489024918Disposable Bipolar Focused Irrigating Forceps, 9", 1.5mm Straight Tips, Box of 5DKIF9-15S2017-03-22
1081748902557120ga Focal Light PipeV2000-20V2017-10-13
1081748902558823ga Focal Light PipeV2000-23R2017-10-13
1081748902559523ga Focal Light PipeV2000-23V2017-10-13
1081748902560125ga Focal Light Pipe V2000-25R2017-10-13
1081748902561825ga Focal Light Pipe V2000-25V2017-10-13
1081748902562527ga Focal Light PipeV2000-27R2017-10-13

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