AccessGUDID - DEVICE: SpaceFlex Hip Instrument Kit (08058964726186)

GUDID

Device Identifier (DI) Information

Brand Name: SpaceFlex Hip Instrument Kit
Version or Model: 900008
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: G21 SRL

Primary DI Number: 08058964726186
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 431529195 *Terms of Use

Device Description: SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to mold temporary prosthesis.

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):	No
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?
45105	Orthopaedic cement spacer mould	A moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MBB	Bone Cement, Antibiotic
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192041	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
No Device Sizes

Device Record Status

Public Device Record Key: a7276257-b923-41b0-921b-e2a544441611
Public Version Date: December 12, 2019
Public Version Number: 1
DI Record Publish Date: December 04, 2019