FDA.report

4CIS® INSTRUMENT SYSTEM

Primary DI
08806373569760
Brand
4CIS® INSTRUMENT SYSTEM
Company
SOLCO BIOMEDICAL CO.,LTD.
Model
9901-4106
Catalog number
9901-4106
Device description
Apollon Container I
Published
2019-03-14
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08806373569760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806373569760088063735697608806373569760

GMDN Terms

TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
687844241
Device count
1
DM exempt
false
Premarket exempt
true
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
088000333436604CIS® INSTRUMENT SYSTEM9807-00019807-00012019-12-25
088000333438824CIS® INSTRUMENT SYSTEM5901-04305901-04302019-12-25
088000333440184CIS® INSTRUMENT SYSTEM5901-01855901-01852019-12-25
088000333444144CIS® INSTRUMENT SYSTEM5901-03405901-03402019-12-25
088000333447424CIS® INSTRUMENT SYSTEM5901-02305901-02302019-11-22
088000333447664CIS® INSTRUMENT SYSTEM5901-02355901-02352019-11-22
088063735959504CIS® INSTRUMENT SYSTEM5901-05925901-05922024-04-01
088063735959674CIS® INSTRUMENT SYSTEM5901-05935901-05932024-04-01
088063735959744CIS® INSTRUMENT SYSTEM5901-05945901-05942024-04-01
088063735959814CIS® INSTRUMENT SYSTEM5901-05955901-05952024-04-01
088063735959984CIS® INSTRUMENT SYSTEM5901-05965901-05962024-04-01
088063735960014CIS® INSTRUMENT SYSTEM5901-05975901-05972024-04-01
088063735960184CIS® INSTRUMENT SYSTEM5901-05985901-05982024-04-01
088063735960254CIS® INSTRUMENT SYSTEM5901-05995901-05992024-04-01
088063735960324CIS® INSTRUMENT SYSTEM5901-06005901-06002024-04-01
088063735960494CIS® INSTRUMENT SYSTEM5901-06015901-06012024-04-01
088063735960564CIS® INSTRUMENT SYSTEM5901-06025901-06022024-04-01
088063735957834CIS® INSTRUMENT SYSTEM4990-24174990-24172024-03-20
088063735957904CIS® INSTRUMENT SYSTEM4901-81414901-81412024-03-20
088063735958064CIS® INSTRUMENT SYSTEM4901-81434901-81432024-03-20

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