FDA.report

4CIS® INSTRUMENT SYSTEM

Primary DI
08800033349198
Brand
4CIS® INSTRUMENT SYSTEM
Company
SOLCO BIOMEDICAL CO.,LTD.
Model
5901-0377
Catalog number
5901-0377
Device description
4CIS® Marlin Trial 12x12 14x12 8degree
Published
2020-04-24
Public version status
New
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
08800033349198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800033349198088000333491988800033349198

GMDN Terms

TermDefinition
Transfemoral amputation tissue-reinforcement implant trialA copy of a final transfemoral amputation tissue-reinforcement implant intended to be used during orthopaedic surgery to accurately size a transfemoral amputation tissue-reinforcement implant (medullary canal rod and bulb) prior to implantation, following a transfemoral (above-the-knee) amputation. It is typically made of metal or polymer materials and includes trial rods and/or trial bulbs; it is typically available in a set of trial implants of graduated sizes. This is a reusable device intended to be sterilized prior to use.

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

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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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