FDA.report

NA

Primary DI
34546540916533
Brand
NA
Company
STRYKER CORPORATION
Model
0700015000
Catalog number
0700015000
Device description
Single Port Manifold
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FYDAPPARATUS, EXHAUST, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34546540916533PackageGS120In Commercial Distribution
04546540916532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3454654091653334546540916533
04546540916532045465409165324546540916532

GMDN Terms

TermDefinition
Surgical fluid/smoke waste management systemAn assembly of devices designed to collect and dispose of both surgical fluid waste and plume smoke generated by surgical procedures involving electrosurgical diathermy, electrocautery, or a laser. It typically consists of a mains electricity (AC-powered) mobile suction unit and a fixed disposal unit. The suction unit uses negative pressure at the site of intervention to collect/filter the fluid/smoke in its containers and filters; it is attached to the disposal unit for automatic container emptying and cleaning. The system is used in the operating room (OR), pathology and surgical centres, and doctor's offices to minimize healthcare worker exposure to harmful fluids/smoke.

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
false
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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