FDA.reportPublic FDA data

SurgyCut

Primary DI
00810014631974
Brand
SurgyCut
Company
U.S. SURGITECH INC.
Model
790-205-535
Device description
SurgyCut Fully Disposable Hook Scissor, 5mm/35cm
Published
2019-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810014631981PackageGS110In Commercial Distribution
00810014631998PackageGS1100In Commercial Distribution
00810014631974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810014631981008100146319818100146319810810014631981
00810014631998008100146319988100146319980810014631998
00810014631974008100146319748100146319740810014631974

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
142007082
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810014639901SurgyCut790SCBF012024-10-10
00810014636832SurgyPad780SP92024-10-10
10810014639908SurgyCut790SCBF012024-10-10
00810014639918SurgyCut790SCGF12024-10-10
00810014631820SurgyCut790-200-535790-200-5352019-03-05
00810014631851SurgyCut790-201-535790-201-5352019-03-20
00810014631882SurgyCut790-202-535790-202-5352019-03-05
00810014631912SurgyCut790-203-535790-203-5352019-03-20
00810014631943SurgyCut790-204-5352019-09-17
00810014632841SurgyCut790-200-5452023-06-09
00810014632872SurgyCut790-201-5452019-10-22
00810014635736SurgyFoam780SP12023-07-31
00810014632575SurgyCut790-119-5452023-06-14
00810014632605SurgyCut790-120-5452023-06-14
00810014632582SurgyCut790-119-5452023-06-14
00810014632612SurgyCut790-120-5452023-06-14
00810014632155SurgyCut790-105-5452023-06-09
00810014632186SurgyCut790-106-5452023-06-09
00810014632216SurgyCut790-107-5452023-06-09
00810014632339SurgyCut790-111-5452023-06-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
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08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
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