FDA.reportPublic FDA data

Cook

Primary DI
00827002145955
Brand
Cook
Company
COOK INCORPORATED
Model
G14595
Catalog number
012365
Device description
Coaxial Sheath Grasping Forceps
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFLDISLODGER, STONE, BASKET, URETERAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFLDislodger, Stone, Basket, Ureteral, MetalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002145955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002145955008270021459558270021459550827002145955

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. 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
042823948
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
false
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
14953170458368DISPOSABLE GRASPING FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.FFL2025-05-14
00810143891300Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFL2025-04-25
00810143891317Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FFL2025-04-25
B0325550200HaloSACRED HEART MEDICAL,INC.FFL2024-07-18
03600040955482DormiaColoplast A/SFFL2024-04-05
03600040955543DormiaColoplast A/SFFL2024-04-05
03600040955598DormiaColoplast A/SFFL2024-04-05
03600040955659Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955727Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955758Dormia N.StoneColoplast A/SFFL2024-04-05
06936534320465Single Use Urinary Stone Retrieval BasketZhejiang Chuangxiang Medical Technology Co., LTD.FFL2023-10-24
16936881136815Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881136822Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881139380Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881139397Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881150095Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16936881150101Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
16944932724331Wellead Stone Retrieval BasketWell Lead Medical Co.,LtdFFL2023-07-12
04055207023273NARichard Wolf GmbHFFL2023-06-20
06971381251647Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
16971381251651Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
16971381251668Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
16971381251675Single-use Extraction BasketsSCIVITA MEDICAL TECHNOLOGY CO., LTD.FFL2023-05-24
03600040326824Dormia DualPercColoplast A/SFFL2023-03-14
03600040326855Dormia DualPercColoplast A/SFFL2023-03-14
04055207018439NARichard Wolf GmbHFFL2022-08-09
04055207023495NARichard Wolf GmbHFFL2022-08-09
B937DOF1511Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF1581Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23
B937DOF2011Domia FrontEPflex Feinwerktechnik GmbH.FFL2021-07-23