AccessGUDID - DEVICE: SMR Shoulder (08033390038812)

GUDID

Device Identifier (DI) Information

Brand Name: SMR Shoulder
Version or Model: Trial Adaptor
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9013.30.020
Company Name: LIMACORPORATE SPA

Primary DI Number: 08033390038812
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432066322 *Terms of Use

Device Description: Trial Adaptor STD Ecc.4mm

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:	No
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?
61003	Humeral head spacer prosthesis trial	A copy of a final humeral head spacer designed to be used before primary or revision implant surgery to validate the appropriate size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is disk-like in shape and made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100858	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: # STD Ecc.4mm

Device Record Status

Public Device Record Key: f5c03ad8-b978-476c-bbf0-9bd380421193
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: April 05, 2016

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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