FDA.report

SSI

Primary DI
00618125160686
Brand
SSI
Company
TIDI PRODUCTS, LLC
Model
27027
Device description
SSI Urology Drain Bags Vinyl Sterile Fits Hoop Style Urology Frames 20 per Case
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MMZTABLE, CYSTOMETRIC, ELECTRIC

Product Code Classifications

CodeDeviceSpecialtyClass
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00618125160686PackageGS120In Commercial Distribution
01618125160685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00618125160686006181251606866181251606860618125160686
01618125160685016181251606851618125160685

GMDN Terms

TermDefinition
Non-wearable urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from a patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
063519193
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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