FDA.reportPublic FDA data

4CIS® INSTRUMENT SYSTEM

Primary DI
08800033349327
Brand
4CIS® INSTRUMENT SYSTEM
Company
SOLCO BIOMEDICAL CO.,LTD.
Model
5901-0404
Catalog number
5901-0404
Device description
4CIS® Marlin Trial 17x15 18x16
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

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800033349327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800033349327088000333493278800033349327

GMDN Terms#

Term, Definition table
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 table
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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