FDA.report

SUR-FIT NATURA

Primary DI
10768455103192
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
401500
Device description
SUR-FIT Natura Drainable Pouch, 12 in, Opaque, with Two Sided Comfort Panel, 1 1/4 in (32 mm)
Published
2018-11-16
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
EZQPouch, Colostomy
FONBag, drainage, with adhesive, ostomy

Product Code Classifications

CodeDeviceSpecialtyClass
EZQPouch, ColostomyGastroenterology, Urology1
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10768455103192PackageGS140In Commercial Distribution
00768455103195PrimaryGS10
00768455182398Unit of UseGS10
80768455103191Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510319210768455103192
00768455103195007684551031957684551031950768455103195
00768455182398007684551823987684551823980768455182398
8076845510319180768455103191

GMDN Terms

TermDefinition
One-piece intestinal ostomy bag, closed-endedA plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-422-8811cic@convatec.com
+18004228811cic@convatec.com
+18004228811cic12@convatec.com

Regulatory Flags

DUNS number
809784593
Device count
10
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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