FDA.reportPublic FDA data

Weitlaner Retractor 14cm Blunt

Primary DI
G25009050130
Brand
Weitlaner Retractor 14cm Blunt
Company
N S SURGICAL COMPANY
Model
09-050-13
Catalog number
09-050-13
Device description
A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G25009050130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Centimeter

Sterilization Methods#

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

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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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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