Primary Device ID | 10886000209936 |
NIH Device Record Key | f9fe73d7-bbb0-49ea-8d69-47cc44adad79 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IBT Flex Resin |
Version Model Number | FLIBFL01 |
Catalog Number | FLIBFL01 |
Company DUNS | 106744280 |
Company Name | FORMLABS OHIO INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Storage Environment Temperature | Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of sunlight |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860002099361 [Primary] |
GS1 | 10886000209936 [Package] Contains: 00860002099361 Package: Case [8 Units] In Commercial Distribution |
EBH | Material, Impression Tray, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-16 |
Device Publish Date | 2023-11-08 |
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