FDA.reportPublic FDA data

Debakey Forceps 1.5mm/15cm

Primary DI
G25003140150
Brand
Debakey Forceps 1.5mm/15cm
Company
N S SURGICAL COMPANY
Model
03-140-15
Catalog number
03-140-15
Device description
A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.
Published
2023-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G25003140150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length15Centimeter

Sterilization Methods#

Method table
Method
"[""Ultraviolet Light"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
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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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
G25010035010Cottle Nasal Speculum 35mm/15cm10-035-0110-035-012023-04-29
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