DEVICE: OsteoMed (00845694007917)
Device Identifier (DI) Information
OsteoMed
250-1606-SP
In Commercial Distribution
250-1606-SP
OSTEOMED LLC
250-1606-SP
In Commercial Distribution
250-1606-SP
OSTEOMED LLC
1.6mm x 6mm Resorbable Screw, 10 Pack
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46637 | Craniofacial bone screw, bioabsorbable |
A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZL | SCREW, FIXATION, INTRAOSSEOUS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 120 Degrees Fahrenheit |
Special Storage Condition, Specify: Care should be taken to keep resorbable plates and screws out of direct sunlight, moisture and excessive heat (greater than 120 DegreeF (45 DegreeC)) while packaged. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 6 Millimeter |
Device Record Status
d9ad2d77-e9af-442c-814a-35615bbea8ed
June 19, 2024
6
April 24, 2015
June 19, 2024
6
April 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)456-7779
1
Customer.Service@osteomed.com
Customer.Service@osteomed.com