FDA.reportPublic FDA data

Single action scissors

Primary DI
16974880993121
Brand
Single action scissors
Company
Suzhou AcuVu medical technology Co., Ltd.
Model
RSI-370-7-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
Rx
false
OTC
false
Sterile
false
Single use
false

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
16974880993121PackageGS11In Commercial Distribution
26974880993128PackageGS15In Commercial Distribution
06974880993124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697488099312116974880993121
2697488099312826974880993128
06974880993124069748809931246974880993124

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
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
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
06974880993179Single action scissorsRSI-370-9-A2025-05-08
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
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
00190776397081MillenniumAvalign Technologies, Inc.LRW2026-07-16
00840183531850BR Surgical, LLCBR Surgical, LLCLRW2026-07-16
00840183531966BR Surgical, LLCBR Surgical, LLCLRW2026-07-16
00190776395575MillenniumAvalign Technologies, Inc.LRW2026-07-14
00190776395582MillenniumAvalign Technologies, Inc.LRW2026-07-14
04059453162618Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-07-13
00850088713022PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713060PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713077PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713084PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713091PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
B382SD9032161000Surgical DirectSurgical Direct, Inc.LRW2026-07-10
B382SD90390213SC0Surgical DirectSurgical Direct, Inc.LRW2026-07-10
00850083275006Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275013Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275037Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275044Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275051Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275068Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275266Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275273Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275297Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275303Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275587Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275716Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275907Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275914Intrace USAPILOTIS TECH LLCLRW2026-07-03
00850083275921Intrace USAPILOTIS TECH LLCLRW2026-07-03
00810055259342Surgical DesignSurgical Design, Inc.LRW2026-06-25
00810055259359Surgical DesignSurgical Design, Inc.LRW2026-06-25