DEVICE: RapidSorb (10887587057255)

Device Identifier (DI) Information

RapidSorb
530.551
In Commercial Distribution
530551
Synthes GmbH
10887587057255
GS1

1
486711679 *Terms of Use
RAPIDSORB IPS POWER DRIVE UNIT
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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?
33541 Bone/joint surgical power tool motor, electric
A hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures such as drilling or sawing of bones and tough tissues; it is not dedicated to dental procedures. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. This is a reusable device.
Active false
46639 Craniofacial bone tack, bioabsorbable
A small, bioabsorbable, cylindrical shaft, typically with a flat, rounded head at one end and tapered to a point at the other, intended to be implanted into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures (e.g., dental regeneration membrane fixation), or to maintain the relative position of bony fragments, bone grafts, or bone graft substitutes. It is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., a degradable polymer), and may be designed to be heated during implantation, with a dedicated inserter, to facilitate its moulding and optimal insertion.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HBW FASTENER, PLATE, CRANIOPLASTY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141385 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d82605e3-bdfb-4440-b004-df75343238ee
September 19, 2024
8
October 07, 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
HIBCC H9805305510
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Unit of Use DI

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

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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