FDA.report

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
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FHNLigator, Hemorrhoidal

Product Code Classifications

CodeDeviceSpecialtyClass
FHNLigator, HemorrhoidalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00197644720941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00197644720941001976447209411976447209410197644720941

GMDN Terms

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

Regulatory Flags

DUNS number
126125922
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860014651113LHC Power Bander LHC Power Bander LLCFHN2026-03-03
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
08033638801727Self-Suction-LEMSAPI MED SPAFHN2026-02-06
16932503532928Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-01-30
06923646508645Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508652Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508669Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508676Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508683Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508690Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508706Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508713Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508720Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508744Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508638Ligation DeviceLeo Medical Co., Ltd.FHN2025-12-18
06923646508737Ligation DeviceLeo Medical Co., Ltd.FHN2025-12-18
00860006350277Snyder HemBandWILBUR HILL LLCFHN2025-09-04
00868852000414EZ Band Hemorrhoidal LigatorWILBUR HILL LLCFHN2025-09-04
00194613121907MSI Precision Specialty InstrumentsMed Saver, Inc.FHN2025-08-01
00190776401757MillenniumAvalign Technologies, Inc.FHN2025-06-12
00858276007410In-SightMicro-tech UsaFHN2025-03-03
00840183529307BR Surgical, LLCBR Surgical, LLCFHN2025-01-03