FDA.report

SUR-FIT NATURA

Primary DI
10768455103291
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
401507
Device description
SUR-FIT Natura Drainable Pouch, 10 in, Opaque, with Two Sided Comfort Panel, 1 3/4 in (45 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
10768455103291PackageGS140In Commercial Distribution
00768455103294PrimaryGS10
00768455182466Unit of UseGS10
80768455103290Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510329110768455103291
00768455103294007684551032947684551032940768455103294
00768455182466007684551824667684551824660768455182466
8076845510329080768455103290

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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