FDA.report

Optitherm

Primary DI
04048551068663
Brand
Optitherm
Company
Karl Storz GmbH & Co. KG
Model
20432030
Device description
Optitherm® Heating Element
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
HIFINSUFFLATOR, LAPAROSCOPIC

Product Code Classifications

CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551068663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551068663040485510686634048551068663

GMDN Terms

TermDefinition
Insufflation gas conditioning systemAn assembly of devices used with a laparoscopic gas distention system or other gas source to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying the gas before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It typically consists of a mains electricity (AC-powered) control unit, a humidification chamber through which cold/dry gas passes for conditioning, and a tubing set for connection to the gas source and delivery of the conditioned gas to the operative site. Conditioning of the gas helps alleviate problems associated with gas insufflation, i.e., desiccation of internal tissue and body temperature loss.

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
true
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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04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

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