FDA.report

n.a.

Primary DI
04048551393802
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
26159LC-S
Device description
LOOP,SPARE, STERILE, BETTOCCHI
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
HIHHYSTEROSCOPE (AND ACCESSORIES)

Product Code Classifications

CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551393802PrimaryGS10
04048551393819Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551393802040485513938024048551393802
04048551393819040485513938194048551393819

GMDN Terms

TermDefinition
Polypectomy endoscopic ligator, reusableA device used in combination with a compatible flexible endoscope for the deployment of a ligature loop (a self-locking device made of, e.g., a polymer in the form of a thin band) that is typically applied to large colorectal or pedunculated polyps in the gastrointestinal (GI) tract to prevent or control bleeding following polypectomy. It typically consists of an insertion sheath, the ligature loop at the distal end, and a control handle at the proximal end used to deploy the loop. This device may be used to ligate the appendix during its removal. 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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