FDA.report

SUR-FIT NATURA

Primary DI
10768455104403
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
404017
Device description
SUR-FIT Natura Drainable Pouch, 12 in, Opaque with 1-Sided Comfort Panel, 2 1/4 in
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
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
10768455104403PackageGS120In Commercial Distribution
00768455104406PrimaryGS10
00768455184866Unit of UseGS10
80768455104402Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510440310768455104403
00768455104406007684551044067684551044060768455104406
00768455184866007684551848667684551848660768455184866
8076845510440280768455104402

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
20
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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