FDA.reportPublic FDA data

Sutter Medical Technologies USA, Inc.

Primary DI
00850006695249
Brand
Sutter Medical Technologies USA, Inc.
Company
SUTTER MEDICAL TECHNOLOGIES USA, INC.
Model
SUT-458SP R
Device description
"Reusable Bipolar Forceps Insulated,Yasargil, Bayonet 6.1"" (15.5cm), 1.5mm Tip, Non-Stick,Irrigation "
Published
2022-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00850006695249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006695249008500066952498500066952490850006695249

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
770-702-7087info@sutter-usa.com

Regulatory Flags#

DUNS number
080438702
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006695447Sutter Medical Technologies USA, IncSUT-376NSSUT-376NS2023-07-05
00850006695454Sutter Medical Technologies USA, IncSUT-381NSSUT-381NS2023-07-05
00850006695461Sutter Medical Technologies USA, IncSUT-384NSSUT-384NS2023-07-05
00850006695201Sutter Medical Technologies USA, Inc.SUT-450SP R2022-08-23
00850006695218Sutter Medical Technologies USA, Inc.SUT-453SP R2022-08-23
00850006695225Sutter Medical Technologies USA, Inc.SUT-455SP R2022-08-23
00850006695232Sutter Medical Technologies USA, Inc.SUT-457SP R2022-08-23
00850006695256Sutter Medical Technologies USA, Inc.SUT-459SP R2022-08-23
00850006695263Sutter Medical Technologies USA, Inc.SUT-460SP R2022-08-23
00850006695270Sutter Medical Technologies USA, Inc.SUT-463SP R2022-08-23
00850006695287Sutter Medical Technologies USA, Inc.SUT-465SP R2022-08-23
00850006695294Sutter Medical Technologies USA, Inc.SUT-467SP R2022-08-23
00850006695300Sutter Medical Technologies USA, Inc.SUT-468SP R2022-08-23
00850006695317Sutter Medical Technologies USA, Inc.SUT-469SP R2022-08-23
00850006695324Sutter Medical Technologies USA, Inc.SUT-530SP R2022-08-23
00850006695331Sutter Medical Technologies USA, Inc.SUT-533SP R2022-08-23
00850006695348Sutter Medical Technologies USA, Inc.SUT-535SP R2022-08-23
00850006695355Sutter Medical Technologies USA, Inc.SUT-537SP R2022-08-23
00850006695362Sutter Medical Technologies USA, Inc.SUT-538SP R2022-08-23
00850006695379Sutter Medical Technologies USA, Inc.SUT-539SP R2022-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848657078399AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
00848657078405AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-07-10
03665415002710Bipolar electrode UNIV / THIN, extra length (round ; Fr26)LAMIDEY NOURY MEDICALGEI2026-07-10
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028750E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09