DEVICE: ELEVATOR, 10mm PERIOSTEAL (00848665030020)

Device Identifier (DI) Information

ELEVATOR, 10mm PERIOSTEAL
0912-100
In Commercial Distribution

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
00848665030020
GS1

1
117858154 *Terms of Use
No description.
CLOSE

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?
38168 Periosteal elevator, reusable
A hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
HSB Rod, Fixation, Intramedullary And Accessories
HWC Screw, Fixation, Bone
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K161913 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

222a929b-16d4-4e7c-992b-b701f514125a
December 04, 2020
2
October 23, 2020
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
310.533.9966
regaffairs@aosortho.com
CLOSE