FDA.report

n.a.

Primary DI
04048551079683
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27085GW
Device description
Sealing
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
FEOLithotriptor, ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
FEOLithotriptor, UltrasonicGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551079683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551079683040485510796834048551079683

GMDN Terms

TermDefinition
Surgical instrument seal/seal maintenance setA seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal.

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
false
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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