FDA.report

SimPro™ Set

Primary DI
07392532189227
Brand
SimPro™ Set
Company
Dentsply Ih AB
Model
5331600
Catalog number
5331600
Device description
Single Use Urinary Catheter with water sachet and Accessories. Female Nelaton 8" 16FR
Published
2017-02-10
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
EZDCATHETER, STRAIGHT

Product Code Classifications

CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07392532189227PackageGS110In Commercial Distribution
07392532189234PackageGS14In Commercial Distribution
07392532189210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07392532189227073925321892277392532189227
07392532189234073925321892347392532189234
07392532189210073925321892107392532189210

GMDN Terms

TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge16French
Length8Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)456-3742AnkaraTUR-Info@wellspect.com

Regulatory Flags

DUNS number
354059073
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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