FDA.reportPublic FDA data

Single action scissors

Primary DI
06974880993179
Brand
Single action scissors
Company
Suzhou AcuVu medical technology Co., Ltd.
Model
RSI-370-9-A
Device description
The single action scissors are intended for use in hysteroscopy procedures for cutting of soft tissue such as polyps from the uterine cavity.
Published
2025-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974880993176PackageGS11In Commercial Distribution
26974880993173PackageGS15In Commercial Distribution
06974880993179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697488099317616974880993176
2697488099317326974880993173
06974880993179069748809931796974880993179

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius45 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6178344997frank.huang@sz-acuvu.com

Regulatory Flags#

DUNS number
705464292
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974880994343Omni® Hysteroscopic GrasperOMNI-G-DSI-0012026-04-17
06974880991441HTx Disposable HysteroscopeHTx60t2025-05-08
06974880991458HTx Disposable HysteroscopeHTx60-L2025-05-08
06974880993124Single action scissorsRSI-370-7-A2025-05-08
06974880993131Biopsy forcepsRSI-370-7-C2025-05-08
06974880993148Serrated forcepsRSI-370-7-D2025-05-08
06974880993155Alligator grasperRSI-370-7-E2025-05-08
06974880993162Hook grasper RSI-370-7-G2025-05-08
06974880993186Biopsy forcepsRSI-370-9-C2025-05-08
06974880993193Serrated forcepsRSI-370-9-D2025-05-08
06974880993209Alligator grasperRSI-370-9-E2025-05-08
06974880993216Hook grasper RSI-370-9-G2025-05-08
06974880993407HTx Disposable HysteroscopeHTx40-L2025-05-08
26974880991445HTx Disposable HysteroscopeHTx60t2025-05-08
26974880991452HTx Disposable HysteroscopeHTx60-L2025-05-08
06974880991632HTx Disposable HysteroscopeHTx60c2025-05-08
16974880993121Single action scissorsRSI-370-7-A2025-05-08
16974880993138Biopsy forcepsRSI-370-7-C2025-05-08
16974880993145Serrated forcepsRSI-370-7-D2025-05-08
16974880993152Alligator grasperRSI-370-7-E2025-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159039702SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039719SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039726SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039733SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039740SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039757SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039764SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039771SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
G425050183SCD0My MedicalMy Medical Store LLCLRW2026-05-04
G425050933SC0My MedicalMy Medical Store LLCLRW2026-03-27
09348811003119INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-03-18
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09348811173058INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
10198956213302CARDINAL HEALTHCardinal Health 200, LLCLRW2025-11-24
09348811000811INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001313INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001702INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811002433INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003171INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003805INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811007117INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
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G453CA303160PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA331700PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA350670PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21