FDA.reportPublic FDA data

Saeed

Primary DI
00827002225534
Brand
Saeed
Company
COOK INCORPORATED
Model
G22553
Catalog number
MBL-6
Device description
Six Shooter Saeed Multi-Band Ligator
Published
2016-09-24
Public version status
Update
Distribution status
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
MNDLigator, esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNDLigator, EsophagealGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002225534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002225534008270022255348270022255340827002225534

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal endoscopic ligator, single-useA device used in combination with a compatible flexible endoscope for the deployment of a rubber band to oesophageal varices during an endoscopic procedure which will create a haemostasis or necrosis of the varix. It is available in various designs and typically consists of a multiple band ligating unit that fits over the distal end of the endoscope with rubber latex ligating bands premounted on a band carrier, and controls that run along the outside of the endoscope terminating in a control handle at the proximal end that is used to deploy the bands as required. In some instances, this type of device could be used to treat haemorrhoids in the colon. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079720472
Device count
1
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16934415066621ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066638ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066645ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066652ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066669ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
16934415066676ZKSKBeijing ZKSK Technology Co.,LtdMND2024-12-06
14953170462396Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
14953170462426Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
14953170462488Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
14953170462549Single Use Rotatable Clip Fixing DeviceOLYMPUS MEDICAL SYSTEMS CORP.MND2024-03-25
06934415023191ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023207ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023214ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023221ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-03
06934415023115ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023122ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023139ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023146ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023153ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023160ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023177ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023184ZKSKBeijing ZKSK Technology Co.,LtdMND2024-01-02
06934415023023ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023030ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023047ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023054ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023061ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023078ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023085ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28
06934415023092ZKSKBeijing ZKSK Technology Co.,LtdMND2023-12-28