FDA.report

EQUIMAT

Primary DI
04048551065297
Brand
EQUIMAT
Company
Karl Storz GmbH & Co. KG
Model
20302030
Device description
Suspension Holder
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
HIGINSUFFLATOR, HYSTEROSCOPIC

Product Code Classifications

CodeDeviceSpecialtyClass
HIGInsufflator, HysteroscopicObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551065297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551065297040485510652974048551065297

GMDN Terms

TermDefinition
Neurological endoscope holderA device intended to be used to hold and fix in position a rigid or flexible endoscope during a diagnostic or therapeutic neurological procedure. It is typically made of high-grade stainless steel and anodized aluminium and will usually be affixed to the operating/examination table enabling the surgeon to freely use both hands. This is a reusable device.

Sterilization Methods

Method

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
false

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04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

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