FDA.reportPublic FDA data

East Coast Surgical Instruments

Primary DI
00850837007198
Brand
East Coast Surgical Instruments
Company
East Coast Surgical Inc.
Model
14-8360
Device description
Ball Tip Electrode 32cm
Published
2017-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850837007198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850837007198008508370071988508370071980850837007198

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009464582
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850837007020East Coast Surgical Instruments14-82062017-08-24
00850837007037East Coast Surgical Instruments 14-8206V2017-08-24
00850837007044East Coast Surgical Instruments14-82142017-08-24
00850837007051East Coast Surgical Instruments14-28206VG-72017-08-24
00850837007068East Coast Surgical Instruments14-28300-VGCV-12017-08-24
00850837007075East Coast Surgical Instruments14-38205VG-12017-08-24
00850837007082East Coast Surgical Instruments14-38205VG-1L2017-08-24
00850837007099East Coast Surgical Instruments14-28206-VGFL2017-08-24
00850837007136East Coast Surgical Instruments14-81002017-08-24
00850837007143East Coast Surgical Instruments14-82002017-08-24
00850837007150East Coast Surgical Instruments14-82052017-08-24
00850837007167East Coast Surgical Instruments14-8300V2017-08-24
00850837007181East Coast Surgical Instruments14-8300CV2017-08-24
00850887007174East Coast Surgical Instruments14-8300CRV2017-08-24
00850837007105East Coast Surgical Instruments14-71022017-08-24
00850837007112East Coast Surgical Instruments14-71032017-08-24
00850837007129East Coast Surgical Instruments14-7103NS2017-08-24

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