THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope 800004

GUDID 38033737710341

THD Surgy is a versatile instrument for multiple applications in proctology. Its compact design allows an easy access to the anus, thus a good dilatation and a gentile retraction of the mucosa, without any trauma to the sphincter. The wide lateral slit allows an optimal visualization of the anal canal and enhanced the operative field. THD Surgy anoscope is the ideal device for all the diagnostic and operative needs in proctology, such as assessment and treatment of all proctological conditions, including haemorrhoids, fistulas, condylomas, polyps, low cancers, etc.

THD SPA

Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use Optical anoscope, single-use
Primary Device ID38033737710341
NIH Device Record Key58ead3ed-b634-4690-bbe7-70bdb69deb1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
Version Model NumberTHD Surgy Mini_Sterile
Catalog Number800004
Company DUNS338430324
Company NameTHD SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com
Phone+390522634311
EmailRegulatory@thdlab.com

Device Dimensions

Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter
Length122.4 Millimeter
Outer Diameter24 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS108033737710340 [Primary]
GS118033737710347 [Package]
Contains: 08033737710340
Package: [8 Units]
In Commercial Distribution
GS128033737710344 [Package]
Contains: 08033737710340
Package: [20 Units]
In Commercial Distribution
GS138033737710341 [Package]
Contains: 18033737710347
Package: [3 Units]
In Commercial Distribution
GS148033737710348 [Package]
Contains: 08033737710340
Package: Cartoon Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCPEndoscope, Ac-Powered And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-11-17
Device Publish Date2016-12-23

On-Brand Devices [THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope]

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18033737710613The Light-Score LED rectoscope is a disposable medical device deemed for investigation of the an
18033737710606The Light-Score LED rectoscope is a disposable medical device deemed for investigation of the an
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18033737710538The Light-Score LED anoscope is a disposable medical device deemed for investigation of the anal
18033737710521THD Light-Scope anoscope is a disposable medical device deemed for investigation of the anal can
18033737710514The THD SURGY light-scope anoscope is a disposable medical device deemed for investigation of th
18033737710507The Light-Score LED anoscope is a disposable medical device deemed for investigation of the anal
18033737710491THD Light-Scope anoscope is a disposable medical device deemed for investigation of the anal can
08033737710487The Light-Score LED anoscope is a disposable medical device deemed for investigation of the anal
18033737710477THD Light-Scope anoscope is a disposable medical device deemed for investigation of the anal can
18033737710460The Light-Scope LED rectoscope is a disposable medical device deemed for investigation of the an
18033737710453The Light-Scope LED rectoscope is a disposable medical device deemed for investigation of the an
18033737710446The Light-Score LED rectoscope is a disposable medical device deemed for investigation of the an
18033737710439The Light-Scope LED rectoscope is a disposable medical device deemed for investigation of the an
18033737710422The THD Light-Scope rectoscope is a disposable medical device deemed for investigation of the an
18033737710415The THD Light-Scope rectoscope is a disposable medical device deemed for investigation of the an
18033737710408The THD Light-Scope rectoscope is a disposable medical device deemed for investigation of the an
18033737710392The THD Light-Scope rectoscope is a disposable medical device deemed for investigation of the an
18033737710385TheTHD rectoscope is a disposable medical device deemed for investigation of the anal canal and
18033737710361TheTHD rectoscope is a disposable medical device deemed for investigation of the anal canal and
38033737710341THD Surgy is a versatile instrument for multiple applications in proctology. Its compact design
38033737710334THD Surgy is a versatile instrument for multiple applications in proctology. Its compact design
28033737710207The THD proctoscope is a disposable medical device deemed for examination and treatment of the a
28033737710191The THD proctoscope is a disposable medical device deemed for examination and treatment of the a
28033737710184The THD proctoscope is a disposable medical device deemed for examination and treatment of the a
28033737710177The THD proctoscope is a disposable medical device deemed for examination and treatment of the a
38033737710167The THD anoscope is a disposable medical device deemed for investigation of the anal canal. Avai
28033737710153The THD anoscope is a disposable medical device deemed for investigation of the anal canal. Avai
38033737710143The THD anoscope is a disposable medical device deemed for investigation of the anal canal. Avai
28033737710139The THD anoscope is a disposable medical device deemed for investigation of the anal canal. Avai
28033737710122The THD anoscope is a disposable medical device deemed for investigation of the anal canal. Avai
28033737710115The THD anoscope is a disposable medical device deemed for investigation of the anal canal. Avai
28033737710108The THD proctoscope is a disposable medical device deemed for examination and treatment of the a
28033737710092The THD proctoscope is a disposable medical device deemed for examination and treatment of the a
28033737710085The THD proctoscope is a disposable medical device deemed for examination and treatment of the a
28033737710078The THD proctoscope is a disposable medical device deemed for examination and treatment of the a
28033737710061The THD anoscope is a disposable medical device deemed for investigation of the anal canal. Avai
28033737710054The THD anoscope is a disposable medical device deemed for investigation of the anal canal. Avai
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