DEVICE: Apfelbaum Caspar Type Odontoid Anterior Cervical Fusion Retractor Titanium Set (10840199543523)
Device Identifier (DI) Information
Apfelbaum Caspar Type Odontoid Anterior Cervical Fusion Retractor Titanium Set
7316-72T
In Commercial Distribution
7316-72T
KOROS U.S.A., INC.
7316-72T
In Commercial Distribution
7316-72T
KOROS U.S.A., INC.
Apfelbaum Caspar Type Odontoid Anterior Cervical Fusion Retractor Titanium Set Consists of the Following:
1 x 7316-73, 1 x 7316-74, 1 x 7316-75, 2 x 7316-76T, 2 x 7316-77T, 2 x 7316-78T, 2 x 7316-79T, 2 x 7316-80T, 2 x 7316-81T, 2 x 7316-82T, 2 x 7316-83T, 1 x 7316-84T, 1 x 7316-85T, 1 x 7316-86T, 1 x 7316-87T, 1 x 7316-88T, 1 x 7316-89T & 1 x 7316-90
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
45182 | Self-retaining surgical retractor, reusable |
A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAD | Retractor |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in dry place at room temperature |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 9x12mm |
Device Record Status
4b5c1716-8a2e-41ef-957a-d965f93f6a56
November 08, 2022
1
October 31, 2022
November 08, 2022
1
October 31, 2022
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
[?]
1-805-529-0825
customerservice@korosUSA.com
customerservice@korosUSA.com