FDA.reportPublic FDA data

Silex

Primary DI
B331EZL1044
Brand
Silex
Company
SILEX MEDICAL, LLC
Model
EZL-1044
Device description
Slide Locking Micro-Fenestrated Dissecting Forceps
Published
2018-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914910000
K933387000
K946263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914910000DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)Davol, Inc.1992-01-06GEI
K933387000BRIMFIELD PRECISION GRASPER/DISSECTORSpringfield Surgical Instruments1993-10-15GCJ
K946263000BRIMFIELD PRECISION GRASPER/DISSECTORSpringfield Surgical Instruments1995-01-26GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B331EZL1044PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic grasping forceps, reusableA rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles that may include a ratchet mechanism; a long slender shaft; and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., duckbill, alligator) controlled by a knob at the handle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
362145604
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B3315851001Signature58510012018-02-13
B331585100145Signature5851001-452018-02-13
B3315851002Signature58510022018-02-13
B331585100245Signature5851002-452018-02-13
B3315851004Signature58510042018-02-14
B3315851005Signature58510052018-02-13
B331585100545Signature5881005-452018-02-13
B3315851006Signature58510062018-02-13
B331585100645Signature5851006-452018-02-13
B3315851018Signature58510182018-02-13
B331585101845Signature5851018-452018-02-13
B3315851022Signature58510222018-02-14
B3315851024Signature58510242018-02-13
B331585102445Signature5851024-452018-02-13
B3315851028Signature58510282018-02-13
B331585102845Signature5851028-452018-02-13
B331585103245Signature5851032-452018-02-13
B3315851033Signature58510332018-02-13
B331585103345Signature5851033-452018-02-13
B3315851034Signature58510342018-02-13

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Primary DI, Brand, Company table
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