FDA.report

BAR 5.5/30/424 HD3 AK HM

Primary DI
04035873066491
Brand
BAR 5.5/30/424 HD3 AK HM
Company
Henke-Sass, Wolf GmbH
Model
8300053460
Catalog number
8300053460
Device description
BAR 5.5/30/424 HD3 AK HM
Published
2020-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04035873066491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04035873066491040358730664914035873066491

GMDN Terms

TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

Device Sizes

TypeValueUnit
Outer Diameter5.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
317326411
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04035873013006HSW LIGMAJECT® I210100010021010001002017-11-06
04035873013020HSW LIGMAJECT® II210200010021020001002017-11-06
04035873027195HSW HENKE-JECT®211800007721180000772018-02-23
04035873033646HSW Cartridge Syringe CW293071810129307181012017-11-06
04035873035817HSW SOFT-JECT® 21030001002018-11-05
04035873035831HSW SOFT-JECT® 83000051972018-11-05
04035873056799HENKE-DENT 3000 SA830001588483000158842018-01-24
04035873057093HENKE-DENT 500 SOFT-GRIP830004238183000423812017-12-22
04035873057109HENKE-DENT 500 SOFT-GRIP830004238283000423822017-12-22
04035873057116HENKE-DENT 500 SOFT-GRIP830004238383000423832017-12-22
04035873057123HENKE-DENT 500 SOFT-GRIP830004238483000423842017-12-22
04035873057130HENKE-DENT 500 SOFT-GRIP830004238583000423852017-12-22
04035873057147HENKE-DENT 500 SOFT-GRIP 830004238683000423862017-12-22
04035873057154HENKE-DENT 500 SOFT-GRIP830004238783000423872017-12-22
04035873057161HENKE-DENT 500 SOFT-GRIP 830004238883000423882017-12-22
04035873055549NA830003857183000385712017-08-04
04035873055556NA830003857283000385722017-08-04
04035873055563NA830003857383000385732017-08-04
04035873055570NA830003857483000385742017-08-04
04035873055587NA830003857583000385752017-08-04

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