FDA.report

SUR-FIT NATURA

Primary DI
10768455116192
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
416948
Device description
Post Op Kit: Natura Two-Piece Urostomy, 2 3/4 in, Transparent, Standard, with Accuseal Tap, with Durahesive Moldable Skin Barrier
Published
2019-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FONBag, Drainage, With Adhesive, Ostomy

Product Code Classifications

CodeDeviceSpecialtyClass
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10768455116192PackageGS16In Commercial Distribution
00768455116195PrimaryGS10
00768455188987Unit of UseGS10
80768455116191Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845511619210768455116192
00768455116195007684551161957684551161950768455116195
00768455188987007684551889877684551889870768455188987
8076845511619180768455116191

GMDN Terms

TermDefinition
Multiple-piece urostomy bag, open-endedA plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-422-8811cic@convatec.com
+18004228811cic@convatec.com

Regulatory Flags

DUNS number
809784593
Device count
5
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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