FDA.report

CONVATEC

Primary DI
00768455157198
Brand
CONVATEC
Company
CONVATEC, PURCHASING DEPARTMENT
Model
422308
Device description
Hydrocolloid Sealing Strips 5X20CM 1X10 INT
Published
2022-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EXEPROTECTOR, OSTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
EXEProtector, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00768455157198PackageGS110In Commercial Distribution
10768455157195PackageGS145In Commercial Distribution
00768455157204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455157198007684551571987684551571980768455157198
1076845515719510768455157195
00768455157204007684551572047684551572040768455157204

GMDN Terms

TermDefinition
Intestinal stoma shield/support belt, single-useA non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. Also known as a stoma protector it is usually attached by the patient to the base plate/wafer that retains the stomal bag, or might be placed directly over the stomal opening when the bag is removed; it may in addition include an attachable ostomy bag protector. This is a single-use device.

Device Sizes

TypeValueUnit
Length5Centimeter
Length20Centimeter
Width5Centimeter
Width20Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+18004228811cic@convatec.com

Regulatory Flags

DUNS number
809784593
Device count
1
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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