Primary Device ID | 07630031730053 |
NIH Device Record Key | 22a296bf-e892-4246-96ef-8daa4178d9a0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Straumann PrefGel |
Version Model Number | PrefGel |
Catalog Number | 075.203W |
Company DUNS | 483599259 |
Company Name | Institut Straumann AG |
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 |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com | |
Phone | +1(800)448-8168 |
info.usa@straumann.com |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Total Volume | 0.6 Milliliter |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07630031730053 [Primary] |
KJJ | CLEANSER, ROOT CANAL |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-09 |
Device Publish Date | 2023-09-30 |
07630031742278 - Straumann TLX Implant System | 2025-06-18 TLX SP Implant, Ø 4.0mm NT, SLA® 8mm, Roxolid® |
07630031742285 - Straumann TLX Implant System | 2025-06-18 TLX SP Implant, Ø 4.0mm NT, SLA® 10mm, Roxolid® |
07630031703064 - Base metal alloy | 2025-06-16 ticon Titanium primary crown |
07630031742261 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 6mm, Roxolid® |
07630031742292 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 12mm, Roxolid® |
07630031742308 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 14mm, Roxolid® |
07630031742315 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 16mm, Roxolid® |
07630031742322 - Straumann TLX Implant System | 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 18mm, Roxolid® |