FDA.reportPublic FDA data

ShortShot

Primary DI
00827002340633
Brand
ShortShot
Company
COOK IRELAND LTD
Model
G34063
Catalog number
HMBL-4-TRI
Device description
Shortshot Saeed Hemorrhoidal Multi-Band Ligator With Triview Anoscope
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00827002340633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002340633008270023406338270023406330827002340633

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry location, at room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
988559035
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002315181EchoTipG31518ECHO-1-222016-09-24
00827002315198EchoTipG31519ECHO-252016-09-24
00827002315204EchoTipG31520ECHO-192016-09-24
00827002347854EchoTip ProCoreG34785ECHO-HD-3-20-C2016-09-24
00827002535855EchoTip ProCoreG53585ECHO-HD-19-C2016-09-24
00827002557369EchoTip ProCoreG55736ECHO-HD-22-C2016-09-24
00827002557383EchoTip ProCoreG55738ECHO-HD-25-C2016-09-24
00827002491427Fusion MarathonG49142FS-MAR-10-52015-10-24
10827002256948JohlinG25694JPWS-8.5-82015-10-24
10827002256955JohlinG25695JPWS-8.5-102015-10-24
10827002257136JohlinG25713JPWS-10-82015-10-24
10827002257143JohlinG25714JPWS-10-102015-10-24
10827002257150JohlinG25715JPWS-10-122015-10-24
10827002257167JohlinG25716JPWS-10-142015-10-24
00827002214392ZimmonG21439ZEBD-11.5-52015-10-24
00827002214422ZimmonG21442ZEBD-11.5-72015-10-24
00827002214460ZimmonG21446ZEBD-11.5-92015-10-24
00827002222076ZimmonG22207ZEBD-11.5-122015-10-24
00827002224421ZimmonG22442ZEBD-11.5-152015-10-24
10827002496658Geenen Sof-FlexG49665GPSO-SF-5-72015-11-03

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