FDA.report

JOURNEY II FASTPAK

Primary DI
00885556808382
Brand
JOURNEY II FASTPAK
Company
Smith & Nephew, Inc.
Model
74012012
Catalog number
74012012
Device description
JOURNEY II FASTPAK SIZE 1-2 RIGHT INSERT TRIALS AND SPACERS 9-13,15 MM
Published
2023-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HWTTEMPLATE

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00885556808382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556808382008855568083828855568083820885556808382

GMDN Terms

TermDefinition
Knee tibia prosthesis trial, single-useA copy of a final tibia prosthesis designed to be used during total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is a one-piece device made of polymer material. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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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00885556884140NA74038846740388462026-02-20

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