Polarcup Instrument Tray Base

Primary DI
09421028114820
Brand
Polarcup Instrument Tray Base
Company
ENZTEC LIMITED
Model
35130080
Catalog number
35130080
Device description
Tray or case used to hold other medical devices
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421028114820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421028114820094210281148209421028114820

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
592616445
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421038412220Enztec XR Trinket M8X1.0-014252-24494252-24492026-03-13
09421038412145Cup reamer handle, offset, Z/H, locking9209-13019209-13012026-03-09
09421038412152Offset coupling, Z/H9209-13069209-13062026-03-09
09421038412169Offset drive train, locking9209-13039209-13032026-03-09
09421038412176Short Offset Cover – United9209-13079209-13072026-03-09
09421038412183Handle – United9209-13059209-13052026-03-09
09421038412299Cup reamer handle, offset, AO, locking9209-13119209-13112026-03-09
09421038412305Offset coupling, AO9209-13139209-13132026-03-09
09421038412312Cup reamer handle, offset, AO, open9209-13129209-13122026-03-09
09421038412329Offset drive train, open9209-13049209-13042026-03-09
09421038412671Cup reamer handle, offset, Z/H, open9209-13029209-13022026-03-09
09421038411865Enztec Modular OCI X4251-31014251-31012026-02-27
09421038411889Adj Dist Fem Alignment Guide – Cartilage4240-77004240-77002026-02-27
09421038411896Adj Dist Fem Alignment Guide – Paddle4240-77014240-77012026-02-27
09421038411902Sagittal Alignment Connector - Pivot4240-77054240-77052026-02-27
09421038411919Sagittal Alignment Connector - Pivot with Fan4240-77064240-77062026-02-27
09421038411926Dist Fem Cut Block Connector – 8mm4240-77104240-77102026-02-27
09421038411933Dist Fem Cut Block Connector – 9mm4240-77114240-77112026-02-27
09421038411940Dist Fem Cut Block Connector – 10mm4240-77124240-77122026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mm4240-77254240-77252026-02-27

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