OSSEOGUARD®
GUDID 00844868041436
OSSEOGUARD® PTFE NON-TEXTURED 25 X 30 - 4 UNIT BOX
BIOMET 3I, LLC
Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable Pliable-polymer dental regeneration membrane, non-bioabsorbable| Primary Device ID | 00844868041436 |
| NIH Device Record Key | 729862a6-2b91-4296-a777-06d7181caf2c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSEOGUARD® |
| Version Model Number | NTXR2530-4 |
| Company DUNS | 186127825 |
| Company Name | BIOMET 3I, LLC |
| Device Count | 4 |
| DM Exempt | true |
| 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 | false |
| 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 |
Customer Support Contacts
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com |
Device Dimensions
| Width | 25 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
| Length | 30 Millimeter |
| Width | 25 Millimeter |
Operating and Storage Conditions
| 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 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844868041436 [Primary] |
| GS1 | 30844868041437 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K964342
FDA Product Code
| LYC | Bone grafting material, synthetic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-04 |
| Device Publish Date | 2019-01-31 |
On-Brand Devices [OSSEOGUARD®]
| 00844868042174 | OSSEOGUARD® PTFE TEXTURED 25 X 30 - 4 UNIT BOX |
| 00844868042167 | OSSEOGUARD® PTFE TEXTURED 25 X 30 |
| 00844868042150 | OSSEOGUARD® PTFE TEXTURED 12 X 24 - 10 UNIT BOX |
| 00844868042143 | OSSEOGUARD® PTFE TEXTURED 12 X 24 |
| 00844868042136 | OSSEOGUARD® PTFE TR250 24 X 38 TRANS CRESTAL - 2 UNIT BOX |
| 00844868042129 | OSSEOGUARD® PTFE TR250 24 X 38 TRANS CRESTAL |
| 00844868042112 | OSSEOGUARD® PTFE TR250 38 X 38 TRANS CRESTAL - 2 UNIT BOX |
| 00844868042105 | OSSEOGUARD® PTFE TR250 38 X 38 TRANS CRESTAL |
| 00844868042099 | OSSEOGUARD® PTFE TR250 25 X 36 SMALL-T - 2 UNIT BOX |
| 00844868042082 | OSSEOGUARD® PTFE TR250 25 X 36 SMALL-T |
| 00844868042075 | OSSEOGUARD® PTFE TR250 30 X 40 RIDGE AUGMENTATION X - 2 UNIT BOX |
| 00844868042068 | OSSEOGUARD® PTFE TR250 30 X 40 RIDGE AUGMENTATION X |
| 00844868042051 | OSSEOGUARD® PTFE TR250 40 X 50 RIDGE AUGMENTATION K - 2 UNIT BOX |
| 00844868042044 | OSSEOGUARD® PTFE TR250 40 X 50 RIDGE AUGMENTATION K |
| 00844868042037 | OSSEOGUARD® PTFE TR250 30 X 40 RIDGE AUGMENTATION K - 2 UNIT BOX |
| 00844868042020 | OSSEOGUARD® PTFE TR250 30 X 40 RIDGE AUGMENTATION K |
| 00844868042013 | OSSEOGUARD® PTFE TR250 13 X 18 PERIO WIDE - 2 UNIT BOX |
| 00844868042006 | OSSEOGUARD® PTFE TR250 13 X 18 PERIO WIDE |
| 00844868041993 | OSSEOGUARD® PTFE TR250 38 X 38 POSTERIOR RIDGE - 2 UNIT BOX |
| 00844868041986 | OSSEOGUARD® PTFE TR250 38 X 38 POSTERIOR RIDGE |
| 00844868041979 | OSSEOGUARD® PTFE TR250 13 X 19 PERIO NARROW - 2 UNIT BOX |
| 00844868041962 | OSSEOGUARD® PTFE TR250 13 X 19 PERIO NARROW |
| 00844868041955 | OSSEOGUARD® PTFE TR250 20 X 25 POSTERIOR EXTRACTION - 2 UNIT BOX |
| 00844868041948 | OSSEOGUARD® PTFE TR250 20 X 25 POSTERIOR EXTRACTION |
| 00844868041931 | OSSEOGUARD® PTFE TR250 25 X 30 POSTERIOR - 2 UNIT BOX |
| 00844868041924 | OSSEOGUARD® PTFE TR250 25 X 30 POSTERIOR |
| 00844868041917 | OSSEOGUARD® PTFE TR250 30 X 41 LARGE-T - 2 UNIT BOX |
| 00844868041900 | OSSEOGUARD® PTFE TR250 30 X 41 LARGE-T |
| 00844868041894 | OSSEOGUARD® PTFE TR250 17 X 25 LARGE FACIAL - 2 UNIT BOX |
| 00844868041887 | OSSEOGUARD® PTFE TR250 17 X 25 LARGE FACIAL |
| 00844868041870 | OSSEOGUARD® PTFE TR250 14 X 24 ANTERIOR EXTRACTION - 2 UNIT BOX |
| 00844868041863 | OSSEOGUARD® PTFE TR250 14 X 24 ANTERIOR EXTRACTION |
| 00844868041856 | OSSEOGUARD® PTFE TR250 12 X 24 ANTERIOR EXTRACTION - 2 UNIT BOX |
| 00844868041849 | OSSEOGUARD® PTFE TR250 12 X 24 ANTERIOR EXTRACTION |
| 00844868041832 | OSSEOGUARD® PTFE TR150 24 X 38 TRANS CRESTAL - 2 UNIT BOX |
| 00844868041825 | OSSEOGUARD® PTFE TR150 24 X 38 TRANS CRESTAL |
| 00844868041818 | OSSEOGUARD® PTFE TR150 38 X 38 TRANS CRESTAL - 2 UNIT BOX |
| 00844868041801 | OSSEOGUARD® PTFE TR150 38 X 38 TRANS CRESTAL |
| 00844868041795 | OSSEOGUARD® PTFE TR150 25 X 36 SMALL-T - 2 UNIT BOX |
| 00844868041788 | OSSEOGUARD® PTFE TR150 25 X 36 SMALL-T |
| 00844868041771 | OSSEOGUARD® PTFE TR150 30 X 40 RIDGE AUGMENTATION X - 2 UNIT BOX |
| 00844868041764 | OSSEOGUARD® PTFE TR150 30 X 40 RIDGE AUGMENTATION X |
| 00844868041757 | OSSEOGUARD® PTFE TR150 40 X 50 RIDGE AUGMENTATION K - 2 UNIT BOX |
| 00844868041740 | OSSEOGUARD® PTFE TR150 40 X 50 RIDGE AUGMENTATION K |
| 00844868041733 | OSSEOGUARD® PTFE TR150 30 X 40 RIDGE AUGMENTATION K - 2 UNIT BOX |
| 00844868041726 | OSSEOGUARD® PTFE TR150 30 X 40 RIDGE AUGMENTATION K |
| 00844868041719 | OSSEOGUARD® PTFE TR150 13 X 18 PERIO WIDE - 2 UNIT BOX |
| 00844868041702 | OSSEOGUARD® PTFE TR150 13 X 18 PERIO WIDE |
| 00844868041696 | OSSEOGUARD® PTFE TR150 38 X 38 POSTERIOR RIDGE - 2 UNIT BOX |
| 00844868041689 | OSSEOGUARD® PTFE TR150 38 X 38 POSTERIOR RIDGE |
Trademark Results [OSSEOGUARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSEOGUARD 77107280 3454688 Live/Registered |
BIOMET 3I, LLC 2007-02-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.