FDA.report

m9

Primary DI
30610075077329
Brand
m9
Company
HOLLISTER INCORPORATED
Model
7732
Catalog number
7732
Device description
Odor Eliminator Spray - Unscented
Published
2022-12-01
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
false

Related Records

Contact Domains

Product Codes

CodeName
EXBCOLLECTOR, OSTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30610075077329PackageGS18In Commercial Distribution
10610075077325PrimaryGS10
00610075088966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3061007507732930610075077329
1061007507732510610075077325
00610075088966006100750889666100750889660610075088966

GMDN Terms

TermDefinition
Ostomy odour-absorbent/deodorizerA device used by an ostomate to absorb unwanted odours and/or emit fragrance to conceal any unpleasant odours emanating from their stoma/ostomy devices. It is available in various forms, such as a powder with anti-odour properties (e.g., Zeolite) or a portable spray, for convenient daily use. After application this device cannot be reused.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags

DUNS number
005527098
Device count
12
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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