FDA.report

Titan Modular Shoulder System 2.5

Primary DI
00885556862971
Brand
Titan Modular Shoulder System 2.5
Company
Smith & Nephew, Inc.
Model
TRL-0920-026-06
Catalog number
TRL-0920-026-06
Device description
TSS HUMERAL STEM TRIAL. 6 MM
Published
2022-12-21
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
false

Related Records

Contact Domains

Product Codes

CodeName
HWTTEMPLATE

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00885556862971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556862971008855568629718855568629710885556862971

GMDN Terms

TermDefinition
Humeral stem prosthesis trial, reusableA copy of a final humeral stem prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is typically made of metal and/or synthetic polymer. This is a reusable device intended to be sterilized prior to use.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00: -

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
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

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