Osteostrip
GUDID 08885013200478
Dimensions: 60 x 3.5 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.
OSTEOPORE INTERNATIONAL PTE. LTD.
Bone matrix implant, synthetic, non-antimicrobial| Primary Device ID | 08885013200478 |
| NIH Device Record Key | 17e86933-eb34-4b1f-9bf0-e2ad2d5400fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osteostrip |
| Version Model Number | PC18(60,3.5,4) |
| Company DUNS | 894834738 |
| Company Name | OSTEOPORE INTERNATIONAL PTE. LTD. |
| 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 | false |
| Serial Number | true |
| 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 | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com | |
| Phone | 9999999999 |
| customerservice@osteopore.com |
Device Dimensions
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
| Length | 60 Millimeter |
| Width | 3.5 Millimeter |
| Depth | 4 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08885013200478 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051093
FDA Product Code
| GXP | Methyl Methacrylate For Cranioplasty |
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 | 2020-08-18 |
| Device Publish Date | 2020-08-10 |
On-Brand Devices [Osteostrip]
| 08885013200485 | Dimensions: 60 x 2 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is |
| 08885013200478 | Dimensions: 60 x 3.5 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler i |
| 08885013200409 | Dimensions: 100 x 2 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is |
| 08885013200195 | Dimensions: 100 x 3.5 x 4 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler |
Trademark Results [Osteostrip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOSTRIP 85840022 4372623 Live/Registered |
ALLIANCE PARTNERS, LLC 2013-02-04 |
 OSTEOSTRIP 75090446 not registered Dead/Abandoned |
X-Ray Technology, Inc. 1996-04-18 |
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