FDA.report

n.a.

Primary DI
04048551393161
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
26040JB1-S
Device description
CUTTING LOOP, BIPOLAR, 24/26FR
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
true
Single use
true

Related Records

Product Codes

CodeName
HINCOAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551393161PrimaryGS10
04048551393178Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551393161040485513931614048551393161
04048551393178040485513931784048551393178

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315731430
Device count
6
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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