FDA.reportPublic FDA data

Captura

Primary DI
10827002536330
Brand
Captura
Company
COOK INCORPORATED
Model
G53633
Catalog number
DBF-2.4SL-230-S
Device description
Captura Serrated Large Forcep - No Spike
Published
2018-09-05
Public version status
New
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
PTSEndoscopic grasping/cutting instrument, non-powered, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002536330PackageGS110In Commercial Distribution
00827002536333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700253633010827002536330
00827002536333008270025363338270025363330827002536333

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, single-useA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. 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
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
06970057579023Disposable Grasping ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.PTS2026-05-22
10816207021741EndoTExtractorENDO-THERAPEUTICS, INC.PTS2026-03-03
06970671381811AltonAlton (Shanghai) Medical Instruments Co., Ltd.PTS2025-08-08
06970671381866AltonAlton (Shanghai) Medical Instruments Co., Ltd.PTS2025-08-08
06970671381880AltonAlton (Shanghai) Medical Instruments Co., Ltd.PTS2025-08-08
06970671381996AltonAlton (Shanghai) Medical Instruments Co., Ltd.PTS2025-08-08
06970671382009AltonAlton (Shanghai) Medical Instruments Co., Ltd.PTS2025-08-08
06970671382016AltonAlton (Shanghai) Medical Instruments Co., Ltd.PTS2025-08-08
06970671382023AltonAlton (Shanghai) Medical Instruments Co., Ltd.PTS2025-08-08
06970671381873AltonAlton (Shanghai) Medical Instruments Co., Ltd.PTS2025-07-25
06970671381903AltonAlton (Shanghai) Medical Instruments Co., Ltd.PTS2025-07-25
16926839810843AnreiAnrei Medical(HZ) Co.,Ltd.PTS2025-07-03
05708265014125LiNA CystoVu™ HD GrasperLina Medical ApSPTS2025-04-18
00850025860635Rotatable Grasping ForcepMicro-tech UsaPTS2025-03-04
16970057579181Disposable Grasping ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.PTS2025-02-26
16971176281528Single use biopsy forceps PGBZhuhai Pusen Medical Technology Co, LtdPTS2025-02-11
16971176281542Single use grasping forceps PGAZhuhai Pusen Medical Technology Co, LtdPTS2025-02-11
06936603227053Disposable Grasping ForcepsYangzhou Fartley Medical Instrument Technology Co., LtdPTS2025-01-21
06926839809178AnreiAnrei Medical(HZ) Co.,Ltd.PTS2025-01-07
06948318963126AnreiAnrei Medical(HZ) Co.,Ltd.PTS2025-01-07
16970057579358Disposable Grasping ForcepsJiangsu Vedkang Medical Science and Technology Co.,Ltd.PTS2024-08-20
00827002560819COOKCOOK INCORPORATEDPTS2024-05-15
00827002560833COOKCOOK INCORPORATEDPTS2024-05-15
14953170463645Single Use Loop Cutter FS-410OLYMPUS MEDICAL SYSTEMS CORP.PTS2024-03-25
16948318996794VersaGrasp Single use Grasping ForcepsAnrei Medical(HZ) Co.,Ltd.PTS2023-11-16
06948318996094VersaGrasp Single use Grasping ForcepsAnrei Medical(HZ) Co.,Ltd.PTS2023-11-01
16932503561072MTMicro-Tech (Nanjing) Co., Ltd.PTS2023-06-28
04260206311263BARS Anchor silverOvesco Endoscopy AGPTS2022-11-22
04260206311270BARS Anchor blackOvesco Endoscopy AGPTS2022-11-22
16959664903282NAHangzhou AGS MedTech Co., Ltd.PTS2022-10-09