FDA.report

SUR-FIT NATURA

Primary DI
10768455133236
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
421043
Device description
Post Op Kit: Natura Stomahesive Moldable Skin Barrier, Accordion Flange, Drainable, with Invisiclose Tail Closure, 22 - 33 mm
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
10768455133236PackageGS16In Commercial Distribution
00768455133239PrimaryGS10
00768455133857Unit of UseGS10
80768455133235Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845513323610768455133236
00768455133239007684551332397684551332390768455133239
00768455133857007684551338577684551338570768455133857
8076845513323580768455133235

GMDN Terms

TermDefinition
One-piece intestinal ostomy bag, open-endedA plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. 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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10768455114822ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
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10768455115720NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455118127ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29