FDA.report

NA

Primary DI
37613252027240
Brand
NA
Company
STRYKER CORPORATION
Model
5450850002
Catalog number
5450850002
Device description
Disposable Suction Canister Liners
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications

CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
37613252027240PackageGS15In Commercial Distribution
07613252027249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3761325202724037613252027240
07613252027249076132520272497613252027249

GMDN Terms

TermDefinition
Bucket linerA device used to line a bucket in order to create a barrier to contamination and serve as the basis for preventing cross-contamination, reducing cleaning requirements, and protecting the bucket surface finish. This liner will typically be used in swab buckets, commonly known as kick buckets. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags

DUNS number
196548481
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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