FDA.report

n.a.

Primary DI
04048551098226
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
28162FK
Device description
Grasping Forceps
Published
2016-09-23
Public version status
Update
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
GWGENDOSCOPE, NEUROLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GWGEndoscope, NeurologicalNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551098226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551098226040485510982264048551098226

GMDN Terms

TermDefinition
Dissection forcepsA surgical instrument used to facilitate grasping, manipulation, compression or joining of tissue during dissection and/or autopsy. It typically has two main designs: 1) a self-retaining, scissors-like design with ring handles with the working end having a variety of blade designs, e.g., straight, angled, or curved with parallel grooves or serrations to provide grip; and 2) tweezers-like design (may be a micro/fine instrument) with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes and may have carbide inserts at the working end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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