AccessGUDID - DEVICE: SMR STEMLESS (08033390107723)

GUDID

Device Identifier (DI) Information

Brand Name: SMR STEMLESS
Version or Model: 1335.15.200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1335.15.200
Company Name: LIMACORPORATE SPA

Primary DI Number: 08033390107723
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432066322 *Terms of Use

Device Description: SMR STEMLESS - NEUTRAL ADAPTOR WITH SCREW

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61002	Humeral head spacer	A sterile implantable component of a total shoulder prosthesis intended to be placed between a standard humeral body and a standard humeral head to serve as a spacer and to achieve the intended varus/valgus alignment. It is in the form of a thick disc with a central or eccentric hole, is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti)], and is used in a modular shoulder replacement system.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: NEUTRAL

Device Record Status

Public Device Record Key: c441283e-e4ba-44d2-98e0-5892cf75f252
Public Version Date: January 08, 2024
Public Version Number: 2
DI Record Publish Date: May 26, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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