DEVICE: GAP ENDO-EXO MEDULLARY SYSTEM (07540194001412)

Device Identifier (DI) Information

GAP ENDO-EXO MEDULLARY SYSTEM
GAP-CS3-80
In Commercial Distribution
GAP-CS3-80
Pega Medical Inc
07540194001412
GS1

1
257315713 *Terms of Use
Cortical Screw Ø3.0mm X 80mm
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44854 Arthrodesis nail, fixed-length
A rod of fixed-length (i.e., not intended for distraction) intended to be implanted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] for the purpose of joint fusion or arthrodesis; it is not dedicated to femur or tibia implantation. The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HSB ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: keep at room temperature
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Clinically Relevant Size

[?]
Size Type Text
Length: 80 Millimeter
Outer Diameter: 3 Millimeter
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Device Record Status

e1808291-5020-443f-ba70-49d2981cba7f
September 18, 2023
4
October 20, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(450)688-5144 242
egarcia@pegamedical.com
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