FDA.reportPublic FDA data

ENSEAL X1

Primary DI
20705036015021
Brand
ENSEAL X1
Company
ETHICON ENDO-SURGERY, LLC
Model
NSLX120L
Catalog number
NSLX120L
Device description
ENSEAL 20 cm shaft, Large Jaw
Published
2017-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGIELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163548000ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC2017-02-14GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705036015021PrimaryGS10
10705036015024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503601502120705036015021
1070503601502410705036015024

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, single-useA sterile 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 single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags#

DUNS number
044606982
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705036046523Megadyne2255JTES2255JTES2026-05-27
10705036003113HARMONICTLB01TLB012016-07-15
20705036003271HARMONICTTBLUETTBLUE2016-07-15
20705036013904N/ACRT11CRT112016-07-15
20705036038396DUALTO Energy SystemETHEF2ETHEF22025-06-18
20705036038402DUALTO Energy SystemETHEF1ETHEF12025-06-18
20705036038419DUALTO Energy SystemETHERFETHERF2025-06-18
20705036038426DUALTO Energy SystemETHCRTETHCRT2025-06-18
20705036039287DUALTO Energy SystemETHOVKETHOVK2025-06-20
20705036038365DUALTO Energy SystemETHCMETHCM2025-06-18
20705036038372DUALTO Energy SystemETHUSCETHUSC2025-06-18
20705036038389DUALTO Energy SystemETHEMETHEM2025-06-18
10705036013143ProximateTCT55TCT552015-08-24
10705036013204PROXIMATETLC55TLC552015-08-24
10705036013006ProximatePPH03PPH032015-08-24
10705036013112ProximateTCD75TCD752015-08-24
10705036013150PROXIMATETCT75TCT752015-08-24
10705036013211PROXIMATETLC75TLC752015-08-24
10705036013389PROXIMATETVC55TVC552015-08-24
10705036002895ETHIBOND; DURAKNOTSW110SW1102016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840113234414BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
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10840113236906BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
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10840113236944BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113236951BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
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10840113237163BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237170BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237187BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237194BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237200BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21
10840113237217BovieASPEN SURGICAL PRODUCTS, INC.HGI2026-09-21