FDA.reportPublic FDA data

Topsuper Med

Primary DI
00197644720941
Brand
Topsuper Med
Company
Topsuper Med, Inc.
Model
TPYZC-3
Published
2023-12-04
Public version status
New
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
FHNLigator, Hemorrhoidal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHNLigator, HemorrhoidalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197644720941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197644720941001976447209411976447209410197644720941

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhoid ligation setA collection of sterile surgical instruments and materials used to locally occlude the blood flow to internal haemorrhoids for their removal. The collection typically includes a ligator preloaded with several ligatures (e.g., latex rubber bands) deployed to the haemorrhoids, an anoscope used to dilate the anus for internal access, and an obturator for insertion of the anoscope. After a ligature has been applied, the haemorrhoid will eventually necrose and pass out of the gut naturally. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
126125922
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955063413AESCULAPAESCULAP, INC.FHN2026-06-06
05055445961923SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961947SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961954SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961961SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961978SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961985SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445961992SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05055445962005SurtexSURTEX INSTRUMENTS LTD.FHN2026-05-12
05060937770006Haemoband-PLUS Band LigatorHaemoband SurgicalFHN2026-04-28
00860014651106LHC Power Bander LHC Power Bander LLCFHN2026-03-03
00860014651113LHC Power Bander LHC Power Bander LLCFHN2026-03-03
06932503532853Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532860Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532877Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532884Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532891Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532907Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532914Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532938Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
06932503532945Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532850Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532867Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532874Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532881Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532898Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532904Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532911Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532935Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532942Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14