FDA.reportPublic FDA data

East Coast Surgical Instruments

Primary DI
00850837007167
Brand
East Coast Surgical Instruments
Company
East Coast Surgical Inc.
Model
14-8300V
Device description
Gold Spatula 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
00850837007167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850837007167008508370071678508370071670850837007167

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
Donation ID number
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
00850837007181East Coast Surgical Instruments14-8300CV2017-08-24
00850837007198East Coast Surgical Instruments14-83602017-08-24
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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