AccessGUDID - DEVICE: SMR (08033390111249)

GUDID

Device Identifier (DI) Information

Brand Name: SMR
Version or Model: HEMISPHERICAL HUMERAL REAMER
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9CCA.13.011
Company Name: LIMACORPORATE SPA

Primary DI Number: 08033390111249
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432066322 *Terms of Use

Device Description: SMR : HEMISPHERICAL HUMERAL REAMER Ø46mm

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?
45114	Bone-resection orthopaedic reamer, reusable	An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112900	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: Dia. 46 mm

Device Record Status

Public Device Record Key: cd5b58e2-1c41-4d2b-bdbb-40445786c1d3
Public Version Date: October 04, 2023
Public Version Number: 6
DI Record Publish Date: August 05, 2016