AccessGUDID - DEVICE: HemiCAP® (M52881351875A0)

GUDID

Device Identifier (DI) Information

Brand Name: HemiCAP®
Version or Model: 8135-1875-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8135-1875-A
Company Name: ARTHROSURFACE INCORPORATED

Primary DI Number: M52881351875A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144666109 *Terms of Use

Device Description: 10.0mm x 31mm, Taper Post, Humeral Head

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?
48094	Shoulder prosthesis screw	A sterile screw or set of screws intended for implantable shoulder prosthesis assembly and/or fixation.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023096	000

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
Outer Diameter: 10.0 Millimeter

Device Record Status

Public Device Record Key: 860195b9-fb37-47d5-97a9-d524e25a3184
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: September 16, 2015