DEVICE: CRANIOPLATE (04046963115432)
Device Identifier (DI) Information
CRANIOPLATE
FM982T
Not in Commercial Distribution
FM982T
Aesculap AG
FM982T
Not in Commercial Distribution
FM982T
Aesculap AG
CRANIOPLATE 1.5 4HOLES STR.L:17MM
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? |
---|---|---|---|---|
61689 | Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile |
A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JEY | PLATE, BONE |
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 |
---|
Device Size Text, specify: Height : 0.600 MM |
Device Record Status
8a28aa86-34bd-4436-8122-269f26ea0271
February 19, 2024
5
September 30, 2015
February 19, 2024
5
September 30, 2015
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:
04038653476862
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com