FDA.reportPublic FDA data

Scalpel Handle No.4

Primary DI
G25001002040
Brand
Scalpel Handle No.4
Company
N S SURGICAL COMPANY
Model
01-002-04
Catalog number
01-002-04
Device description
A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.
Published
2023-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G25001002040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12.5Centimeter

Sterilization Methods#

Method table
Method
"[""Ultraviolet Light"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

Regulatory Flags#

DUNS number
645681649
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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G25012191240Lambotte Osteotomes Straight 38mm12-191-2412-191-242023-09-02
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G25010005140Laborde Dilator Forcep10-005-1410-005-142023-04-29
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G25003168240Debakey Satinsky Forceps 24cm03-168-2403-168-242023-04-28
G25003178000Vasectomy Set of 203-178-0003-178-002023-04-29
G25008036030Penfield Elevator08-036-0308-036-032023-04-28
G25009006010Volkmann Retractor 1 Prong Sharp09-006-0109-006-012023-04-29
G25009047020Weitlaner Retractor 20cm Blunt 3x409-047-0209-047-022023-04-28
G25009047190Anderson Retractor 19cm Blunt 4x409-047-1909-047-192023-04-28
G25009050130Weitlaner Retractor 14cm Blunt09-050-1309-050-132023-04-28
G25010034030Killian Nasal Speculum 75mm/13cm10-034-0310-034-032023-04-29
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