FDA.reportPublic FDA data

Drain-TG

Primary DI
08800200200031
Brand
Drain-TG
Company
JSR MEDICAL CO., LTD.
Model
DTG02-18
Device description
Guide, Surgical, Instrument
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800200200038PrimaryGS10
28800200200035PrimaryGS10
08800200200031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880020020003818800200200038
2880020020003528800200200035
08800200200031088002002000318800200200031

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-useA device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+821038298824ymseo@jsrmed.co.kr

Regulatory Flags#

DUNS number
694626026
Device count
4
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18800200200076Drain-TGDTG02-152026-03-23
18800200200083Drain-TGDTG02-222026-03-23
28800200200073Drain-TGDTG02-152026-03-23
28800200200080Drain-TGDTG02-222026-03-23
08800200200079Drain-TGDTG02-152026-03-23
08800200200086Drain-TGDTG02-222026-03-23
18800200200038Drain-TGDTG02-182023-08-10
18800200200052Drain-TGDTG02-JP2023-08-10
28800200200035Drain-TGDTG02-182023-08-10
28800200200059Drain-TGDTG02-JP2023-08-10
08800200200055Drain-TGDTG02-JP2023-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337121657Working Tube with long lipJoimax GmbHFZX2026-08-19
00810111225465joint seekerTreace Medical Concepts, Inc.FZX2026-08-17
06936666566724CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06936666566731CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653161CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653321CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653475CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653499CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278654793CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278654809CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
00810111225427TargeterTreace Medical Concepts, Inc.FZX2026-08-14
00810111225434TargeterTreace Medical Concepts, Inc.FZX2026-08-14
00190776411091MillenniumAvalign Technologies, Inc.FZX2026-08-07
06438408012815Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012822Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012839Inion CompressOn™ InstrumentInion OyFZX2026-08-07
00840606191838Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
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00190376544496InvictusALPHATEC SPINE, INC.FZX2026-07-30
03701089528054AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089542548AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543316AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543330AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543354AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543378AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543682AMPLITUDEAMPLITUDE SASFZX2026-07-29
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03700569674342Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674281Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
03700569674298Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27