Primary Device ID | 00850018568203 |
NIH Device Record Key | 23957733-5326-4e38-99ea-2443ea74d768 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | G21 Flex Beads, 10cc |
Version Model Number | 900217 10 |
Catalog Number | 900217 10 |
Company DUNS | 080276169 |
Company Name | DIMENSIONAL BIOCERAMICS LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850018568203 [Primary] |
MQV | Filler, Bone Void, Calcium Compound |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-14 |
Device Publish Date | 2024-06-06 |
00850018568197 - G21 Flex Beads, 5cc | 2024-06-14 CALCIUM SULFATE BONE VOID FILLER |
00850018568203 - G21 Flex Beads, 10cc | 2024-06-14CALCIUM SULFATE BONE VOID FILLER |
00850018568203 - G21 Flex Beads, 10cc | 2024-06-14 CALCIUM SULFATE BONE VOID FILLER |
00850018568210 - G21 Flex Beads, 20cc | 2024-06-14 CALCIUM SULFATE BONE VOID FILLER |
00850018568081 - Arthrex Calcium Sulfate BioBeads, 5 cc | 2023-09-13 BONE VOID FILLER |
00850018568098 - Arthrex Calcium Sulfate BioBeads, 10 cc | 2023-09-13 BONE VOID FILLER |
00850018568180 - Arthrex Calcium Sulfate BioBeads, 20 cc | 2023-09-13 BONE VOID FILLER |
00850018568005 - OsteoRepair-Paste | 2021-07-13 BONE VOID FILLER |
00850018568012 - OsteoRepair-Paste | 2021-07-13 BONE VOID FILLER |