FDA.report

Drain-TG

Primary DI
08800200200055
Company
JSR MEDICAL CO., LTD.
Model
DTG02-JP
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

Related Records

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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
18800200200052PrimaryGS10
28800200200059PrimaryGS10
08800200200055Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
18800200200052PrimaryGS10
28800200200059PrimaryGS10
08800200200055Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FZXGuide, Surgical, Instrument1General, Plastic Surgery878.4800NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+821038298824ymseo@jsrmed.co.kr

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800200200079Drain-TGDTG02-152026-03-23
08800200200086Drain-TGDTG02-222026-03-23
08800200200031Drain-TGDTG02-182023-08-10

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