FDA.reportPublic FDA data

Sutter Medical Technologies USA, Inc

Primary DI
00850006695454
Brand
Sutter Medical Technologies USA, Inc
Company
SUTTER MEDICAL TECHNOLOGIES USA, INC.
Model
SUT-381NS
Catalog number
SUT-381NS
Device description
"Reusable Bipolar Forceps Insulated, Adson, Straight 5.0"" (12.7cm), 1.2mm Tip, Non-Stick"
Published
2023-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00850006695454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006695454008500066954548500066954540850006695454

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

Regulatory Flags#

DUNS number
080438702
Device count
1
Lot or batch
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
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
00850006695249Sutter Medical Technologies USA, Inc.SUT-458SP 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

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Primary DI, Brand, Company table
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B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
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08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16