FDA.reportPublic FDA data

N/A

Primary DI
07613327545722
Brand
N/A
Company
Stryker GmbH
Model
I-U0343S48
Catalog number
I-U0343S48
Device description
Slotted Head Sizer
Published
2022-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327545722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327545722076133275457227613327545722

GMDN Terms#

Term, Definition table
TermDefinition
Humeral head prosthesis trial, reusableA copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327605716PANGEA5422525422522026-06-02
07613327648331PANGEA5421605421602026-06-02
07613327648355PANGEA7039197039192026-06-02
07613327648362PANGEA5421615421612026-06-02
07613327648379PANGEA7039187039182026-06-02
37613153159729PROFYLE59-1204959-120492015-09-24
37613153159736PROFYLE59-1704959-170492015-06-24
37613153159743PROFYLE59-2304959-230492015-07-03
07613154583829PROFYLE59-12049E59-12049E2015-06-24
07613154583836PROFYLE59-17049E59-17049E2015-06-24
07613154583843PROFYLE59-23049E59-23049E2015-07-03
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27

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