FDA.report

n.a.

Primary DI
04048551193266
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
722005
Device description
Laser Application Insert f.722000
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
GEXPowered laser surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551193266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551193266040485511932664048551193266

GMDN Terms

TermDefinition
Sharp surgical instrument counting tray/pad, reusableA device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. 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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