FDA.reportPublic FDA data

Straight Cup, Straight Handle, 3.5mm diameter, 220mm

Primary DI
00856312006434
Brand
Straight Cup, Straight Handle, 3.5mm diameter, 220mm
Company
KATALYST SURGICAL LLC
Model
N2102
Device description
Each, Bone Curette, 3.5mm, 220mm
Published
2016-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856312006434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856312006434008563120064348563120064340856312006434

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007883297
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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10817489027513Laser Probe OS4, MultiFlex Inverted, 25gaVK4003152019-03-19
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10817489027544Laser Probe OS4, MultiFlex Inverted Extendable, 23gaVK4003332019-03-19
10817489027551Laser Probe OS4, MultiFlex Inverted Extendable, 25gaVK4003352019-03-19
1084009621123520ga Straight Laser Probe6202002020-03-04
1084009621124223ga Straight Laser Probe6202012020-03-04
1084009621125925ga Straight Laser Probe6202022020-03-04
1084009621126627ga Straight Laser Probe6202032020-03-04
1084009621127323ga Flexible Curved Laser Probe6202102020-03-04
1084009621128025ga Flexible Curved Laser Probe6202112020-03-04
1084009621129727ga Flexible Curved Laser Probe6202122020-03-04
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1084009621131023ga Illuminated Straight Laser Probe6202212020-03-04
1084009621132725ga Illuminated Straight Laser Probe6202222020-03-04
1084009621133427ga Illuminated Straight Laser Probe6202232020-03-04
1084009621134123ga Illuminated Flexible Curved Laser Probe6202292020-03-04
1084009621135825ga Illuminated Flexible Curved Laser Probe6202302020-03-04

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