FDA.reportPublic FDA data

Sheathe Blade

Primary DI
08800322775646
Brand
Sheathe Blade
Company
GS Medical Co., Ltd.
Model
GS152-1101
Catalog number
GS152-1101
Device description
Endoscope
Published
2026-09-18
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800322775646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800322775646088003227756468800322775646

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82432377393udimail@gsmedi.com

Regulatory Flags#

DUNS number
688385418
Device count
1
DM exempt
true
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
08800322775561Sheathe BladeGS152-1001GS152-10012026-09-18
08800322775578Sheathe BladeGS152-1002GS152-10022026-09-18
08800322775585Sheathe BladeGS152-1003GS152-10032026-09-18
08800322775592Sheathe BladeGS152-1004GS152-10042026-09-18
08800322775608Sheathe BladeGS152-1005GS152-10052026-09-18
08800322775615Sheathe BladeGS152-1006GS152-10062026-09-18
08800322775622Sheathe BladeGS152-1007GS152-10072026-09-18
08800322775639Sheathe BladeGS152-1008GS152-10082026-09-18
08800322775653Sheathe BladeGS152-1102GS152-11022026-09-18
08800322775660Sheathe BladeGS152-1103GS152-11032026-09-18
08800322775677Sheathe BladeGS152-1104GS152-11042026-09-18
08800322775684Sheathe BladeGS152-1105GS152-11052026-09-18
08800322775691Sheathe BladeGS152-1106GS152-11062026-09-18
08800322775707Sheathe BladeGS152-1107GS152-11072026-09-18
08800322775714Sheathe BladeGS152-1108GS152-11082026-09-18
08800322776391QUASAR Standalone ACIF System6008-00056008-00052026-09-18
08800322776407QUASAR Standalone ACIF System6008-00066008-00062026-09-18
08800322776414QUASAR Standalone ACIF System6008-00076008-00072026-09-18
08800322776421QUASAR Standalone ACIF System6008-00086008-00082026-09-18
08800322776438QUASAR Standalone ACIF System6008-00096008-00092026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841536148640ThompsonThompson Surgical Instruments, Inc.GAD2026-09-20
08800322775561Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775578Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775585Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775592Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775608Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775615Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775622Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775639Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775653Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775660Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775677Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775684Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775691Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775707Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775714Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776872Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776889Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776896Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776902Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04
00190776428129MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428259MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428266MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428273MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428280MillenniumAvalign Technologies, Inc.GAD2026-08-27
00192896123663Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27