FDA.report

Securi-T

Primary DI
10610075069481
Brand
Securi-T
Company
HOLLISTER INCORPORATED
Model
7135005
Catalog number
7135005
Device description
Closed Tail Closure
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
10610075069481PackageGS1200In Commercial Distribution
00610075069484PrimaryGS10
20610075069488Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007506948110610075069481
00610075069484006100750694846100750694840610075069484
2061007506948820610075069488

GMDN Terms

TermDefinition
Ostomy bag closure deviceA device intended to facilitate the emptying and/or reclosure of an open-ended ostomy bag. This is a reusable device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
005527098
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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10610075099518CeraPlus89001C89001C2026-03-01
10610075099525CeraPlus89002C89002C2026-03-01
10610075099600CeraPlus89003C89003C2026-03-01
10610075099617CeraPlus89004C89004C2026-03-01
10610075099624CeraPlus89005C89005C2026-03-01
20610075091922VaPro72082720822026-01-30
20610075092585VaPro72102721022026-01-30
20610075092592VaPro72122721222026-01-30
20610075092608VaPro72142721422026-01-30
20610075092615VaPro72084720842026-01-30
20610075092622VaPro72104721042026-01-30

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