FDA.report

Marcon-Haber

Primary DI
00827002223912
Brand
Marcon-Haber
Company
COOK INCORPORATED
Model
G22391
Catalog number
MHI-21
Device description
Marcon-Haber Varices Injector
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

Related Records

Contact Domains

Product Codes

CodeName
FBKendoscopic injection needle, gastroenterology-urology

Product Code Classifications

CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K851952000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K851952000VARICES INJECTORWilson-Cook Medical, Inc.1985-07-26FBK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002223912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002223912008270022239128270022239120827002223912

GMDN Terms

TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an 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
false
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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