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SLATE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30110997793011099779Slater Endoscopy, LLC1N2026-01-0110306 USA Today Way Miramar FL US 33025
30203933023020393302Slate Dental, Inc.1N2026-01-013602 S Jefferson Dr Spokane WA US 99203

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M707ES26165ENSIZOR - The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.305-889-3350jstarkey@slaterendoscopy.com
M707ES26165ENSIZOR - The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.305-889-3350crslater@slaterendoscopy.com
M707ES26235ENSIZOR - The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 235 cm.305-889-3350crslater@slaterendoscopy.com
M707ES26235ENSIZOR - The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 235 cm.305-889-3350jstarkey@slaterendoscopy.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1737201264217498K180134Ensizor Monopolar Endoscopic ScissorsKGE2018-06-29
1737201977650856K150939Ensizor Endoscopic ScissorsOCZ2015-06-08
1737201697076876K141058ENSIZOR ENDOSCOPIC SCISSORSOCZ2014-08-01
2994121254529697
2994121488768255
2994121600231493
2994121795230053

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCZ22015-06-08
KGE12018-06-29

NDC#

acyclovir

Slate Run Pharmaceuticals, LLC

acyclovir

daptomycin

Slate Run Pharmaceuticals, LLC

daptomycin

lincomycin

Slate Run Pharmaceuticals, LLC

lincomycin

lincomycin

Slate Run Pharmaceuticals, LLC

lincomycin

Guanfacine

Slate Run Pharmaceuticals, LLC

guanfacine

Guanfacine

Slate Run Pharmaceuticals, LLC

guanfacine

Guanfacine

Slate Run Pharmaceuticals, LLC

guanfacine

Guanfacine

Slate Run Pharmaceuticals, LLC

guanfacine

119 records. Showing 1-40. Next

PMN#

Applications#

GUDID#

ENSIZOR - The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 235 cm.

SLATER ENDOSCOPY LLC

2016-08-23

ENSIZOR - The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.

SLATER ENDOSCOPY LLC

2016-08-23