FDA.reportPublic FDA data

ParallelPortal

Primary DI
37613327055833
Brand
ParallelPortal
Company
STRYKER CORPORATION
Model
3911004055
Catalog number
3911-004-055
Device description
Cannula
Published
2019-10-28
Public version status
New
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
NBHAccessories, arthroscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
37613327055833PackageGS15In Commercial Distribution
07613327055832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3761332705583337613327055833
07613327055832076133270558327613327055832

GMDN Terms

TermDefinition
Arthroscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device.

Device Sizes

TypeValueUnit
Length55Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags

DUNS number
187502109
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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