FDA.reportPublic FDA data

Drain-TG

Primary DI
28800200200035
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
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
28800200200035PrimaryGS10
08800200200031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

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

Contacts#

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

Regulatory Flags#

DUNS number
694626026
Device count
4
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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
28800200200059Drain-TGDTG02-JP2023-08-10
08800200200031Drain-TGDTG02-182023-08-10
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
00840606191845Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
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
03700569674335Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674342Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674281Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
03700569674298Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27