Model: GYQSMUSV1Q16
Catalog: GYQSMUSV1Q16
DI: 03760191134034
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
Injectable Macroporous Calcium Phosphate - QUICKSET, 16cc
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
99522f8e-da7b-4426-8aba-467cf1925882
Distribution Status:
In Commercial Distribution
DUNS Number:
279959048
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
03760191134034
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17751
Name: Bone matrix implant, synthetic, non-antimicrobial
Definition:
A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it 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. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.
FDA Product Codes
MQV
Filler, Bone Void, Calcium Compound
Premarket Submissions
Item #1 - Submission Number:
K093343
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K231714
Item #2 - Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Milliliter
Device Size - Size - @attributes - Value:
16
Device Size - Size Type:
Total Volume
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature