FDA.reportPublic FDA data

SPACEBANDER

Primary DI
20653405005466
Brand
SPACEBANDER
Company
Conmed Corporation
Model
HB1020
Catalog number
HB1020
Device description
SPACEBANDER DISPOSABLE HEMORRHOID LIGATOR
Published
2018-04-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
20653405005466PackageGS120Not in Commercial Distribution
10653405005469PrimaryGS10
00653405005462Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340500546620653405005466
1065340500546910653405005469
00653405005462006534050054626534050054620653405005462

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhoid ligatorA hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
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30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
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20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

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Primary DI, Brand, Company table
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