FDA.reportPublic FDA data

Captura

Primary DI
10827002536309
Brand
Captura
Company
COOK INCORPORATED
Model
G53630
Catalog number
DBF-2.4SL-160-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
10827002536309PackageGS110In Commercial Distribution
00827002536302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700253630910827002536309
00827002536302008270025363028270025363020827002536302

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
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934415028424ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029865ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029872ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029889ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029896ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029902ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029919ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029926ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029933ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029940ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029957ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029964ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029971ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029988ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415029995ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030007ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030014ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030021ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030038ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030045ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030052ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030069ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030076ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030083ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030090ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030106ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030113ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030120ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030137ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18
06934415030144ZKSKBeijing ZKSK Technology Co.,LtdPTS2026-05-18