AccessGUDID - DEVICE: SKaffold (00813845020719)

GUDID

Device Identifier (DI) Information

Brand Name: SKaffold
Version or Model: CMMX-FL10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CMMX-FL10
Company Name: SKELETAL KINETICS LLC

Primary DI Number: 00813845020719
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 140071411 *Terms of Use

Device Description: SKaffold CMF Flow Bone Void Filler Mixing and Delivery System

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:	Yes
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?
17751	Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial	A bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXP	METHYL METHACRYLATE FOR CRANIOPLASTY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: bcc54039-1d74-47f3-b822-ba15180eb0a3
Public Version Date: October 16, 2026
Public Version Number: 7
DI Record Publish Date: October 30, 2015