DEVICE: NA (00840085220432)
Device Identifier (DI) Information
NA
KZC020010
In Commercial Distribution
KZC020010
HYHTE HOLDINGS, INC.
KZC020010
In Commercial Distribution
KZC020010
HYHTE HOLDINGS, INC.
ADJUSTABLE DEPTH AWL, VARIABLE ANGLE
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? |
---|---|---|---|---|
15275 | Bone awl, reusable |
A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
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
7ddd04ca-3310-461d-8871-946607e3abcc
June 10, 2022
2
July 30, 2021
June 10, 2022
2
July 30, 2021
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 |
---|---|
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
[?]
7608148047
PARKER@ASTURAMEDICAL.COM
PARKER@ASTURAMEDICAL.COM