AccessGUDID - DEVICE: Ingen SEVIIN® Shoulder System (B59910536100)

GUDID

Device Identifier (DI) Information

Brand Name: Ingen SEVIIN® Shoulder System
Version or Model: 105-36-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 105-36-10
Company Name: INGEN ORTHOPEDICS, L.L.C.

Primary DI Number: B59910536100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187232066 *Terms of Use

Device Description: REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +0 MM

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?
33711	Total reverse shoulder prosthesis	A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PHX	Shoulder Prosthesis, Reverse Configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120374	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
No Device Sizes

Device Record Status

Public Device Record Key: b3498ba9-24c1-491e-9dbe-59646b69c857
Public Version Date: March 28, 2019
Public Version Number: 1
DI Record Publish Date: March 20, 2019