DEVICE: Oxboro™ Pin Cover (00887761003156)
Device Identifier (DI) Information
Oxboro™ Pin Cover
101003PBX
Not in Commercial Distribution
ASPEN SURGICAL PRODUCTS, INC.
101003PBX
Not in Commercial Distribution
ASPEN SURGICAL PRODUCTS, INC.
Single use device intended to cover exposed ends of orthopedic pin and k-wires to help protect the exposed wire from snagging on clothing.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
17812 | Needle guard |
A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d4dc10d6-c41d-427c-9feb-e8088cc0ed85
June 10, 2022
4
May 31, 2019
June 10, 2022
4
May 31, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10887761003153 | 30 | 00887761003156 | 2021-12-15 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
80887761003152
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(616)698-7100
customerservice@aspensurgical.com
customerservice@aspensurgical.com