FDA.report

Captura

Primary DI
10827002315768
Brand
Captura
Company
COOK INCORPORATED
Model
G31576
Catalog number
DBF-2.4-230-S
Device description
Captura Biopsy Forceps Without 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

Related Records

Contact Domains

Product Codes

CodeName
PTSEndoscopic grasping/cutting instrument, non-powered, exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10827002315768PackageGS110In Commercial Distribution
00827002315761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700231576810827002315768
00827002315761008270023157618270023157610827002315761

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods

Method

Contacts

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

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