Harrison

Primary DI
00827002167667
Brand
Harrison
Company
COOK INCORPORATED
Model
G16766
Catalog number
J-HFBS-503540
Device description
Harrison Fetal Bladder Stent Set
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MPRStent,bladder,fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPRStent, Bladder, FetalUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002167667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002167667008270021676678270021676670827002167667

GMDN Terms#

Term, Definition table
TermDefinition
Foetal bladder shuntA sterile non-bioabsorbable tubular device intended to be implanted in the bladder of a foetus with post-vesicular obstructive uropathy, to decompress the urinary tract by providing a temporary drainage route for urine from the bladder into the amniotic sac, until the defect can be surgically repaired after birth. It is made of synthetic polymer materials and is typically designed with retention features (e.g., double pigtail). It is inserted through the maternal abdominal wall via a percutaneous suprapubic access tract, under ultrasound guidance; disposable devices to assist implantation are typically included.

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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