FDA.reportPublic FDA data

N/A

Primary DI
04035873068655
Brand
N/A
Company
Henke-Sass, Wolf GmbH
Model
8300053515
Catalog number
8300053515
Device description
OPTICAL SCISSORS, HOOK-SHAPED
Published
2021-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NWWHysteroscope Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035873068655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035873068655040358730686554035873068655

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, reusableA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317326411
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035873059776HSW HENKE-JECT®485000300048500030002020-12-09
04035873055549NA830003857183000385712017-08-04
04035873055556NA830003857283000385722017-08-04
04035873055563NA830003857383000385732017-08-04
04035873055570NA830003857483000385742017-08-04
04035873055587NA830003857583000385752017-08-04
04035873055594NA830003857683000385762017-08-04
04035873055600NA830003857883000385782017-08-04
04035873055617NA830003874583000387452017-08-04
04035873068709N/A830005352083000535202021-02-19
04035873068723N/A830005352283000535222021-02-19
04035873068730N/A830005352383000535232021-02-19
04035873069188N/A830005490883000549082021-02-19
04035873068679N/A830005351783000535172021-02-18
04035873068686N/A830005351883000535182021-02-18
04035873068693N/A830005351983000535192021-02-18
04035873068716N/A830005352183000535212021-02-18
04035873067788N/A830005474983000547492021-02-16
04035873066538N/A830005347583000534752021-02-12
04035873066569N/A830005347883000534782021-02-12

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Primary DI, Brand, Company table
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05708265017942LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017980LiNA OperaScope™ ScissorsLiNA Medical AGNWW2026-04-03
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