FDA.reportPublic FDA data

SUR-FIT NATURA

Primary DI
10768455107152
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
404011
Device description
SUR-FIT Natura® Disposable Convex Inserts, 1 3/8" Inner Diameter, Flange Size 1 3/4"
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZSAPPLIANCE, COLOSTOMY, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZSAppliance, Colostomy, DisposableGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455107152PackageGS112In Commercial Distribution
00768455107155PrimaryGS10
00768455184804Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510715210768455107152
00768455107155007684551071557684551071550768455107155
00768455184804007684551848047684551848040768455184804

GMDN Terms#

Term, Definition table
TermDefinition
Ostomy convexity insertA device designed to help improve contact between the flange of a two-piece or multiple-piece ostomy appliance and the peristomal skin of a flush stoma or more typically a recessed stoma (a stoma with an adjacent depression, scar, crease, or other condition) for which additional barrier-to-skin contact is desirable. The device is placed between the ostomy appliance flange and the stomal skin typically to fill gaps between the two by providing convexity (an outward bulge), reducing the likelihood of leakage. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10768455203946ESTEEM4236452024-09-13
10768455209481ESENTA4238272024-08-26
10768455209511ESENTA4238262024-08-26
00768455204793GENTLECATH5106002024-04-05
00768455204823GENTLECATH5106012024-04-05
00768455204854GENTLECATH5106022024-04-05
00768455207145GENTLECATH5106032024-04-05
00768455207169GENTLECATH5106042024-04-05
00768455207206GENTLECATH5106052024-04-05
10815947021172CURE PRODUCTSHM16UK2024-03-30
10768455203922ESTEEM4236432024-03-20
10768455203939ESTEEM4236442024-03-20
10768455203953ESTEEM4236462024-03-20
10768455203960ESTEEM4236472024-03-20
10768455203977ESTEEM4236482024-03-20
10768455204004ESTEEM4236512024-03-20
10768455204011ESTEEM4236522024-03-20
10768455204028ESTEEM4236532024-03-20
10768455204035ESTEEM4236542024-03-20
10768455204059ESTEEM4236562024-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20885632431163HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431200HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431217HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431248HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431122HalyardO&M HALYARD, INC.EZS2024-11-12
20885632431132HalyardO&M HALYARD, INC.EZS2024-11-12
20885632431149HalyardO&M HALYARD, INC.EZS2024-11-12
30885632431153HalyardO&M HALYARD, INC.EZS2024-11-12
30885632431221HalyardO&M HALYARD, INC.EZS2024-11-12
30885632431238HalyardO&M HALYARD, INC.EZS2024-11-12
20885632434706HalyardO&M HALYARD, INC.EZS2024-11-12
20885632434713HalyardO&M HALYARD, INC.EZS2024-11-12
00810040134760Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134869Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134890Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134920Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134951Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134982Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135019Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135040Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135101Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135132Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135071Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134838Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135316Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135347Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135378Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135408Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040135439Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134791Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08