DEVICE: RapidSorb (10887587057262)

Device Identifier (DI) Information

RapidSorb
530.553.01S
In Commercial Distribution
53055301S
Synthes GmbH
10887587057262
GS1

1
486711679 *Terms of Use
RAPIDSORB IPS BATTERY PACK STERILE
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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
36534 Portable/mobile rechargeable battery pack
A group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.
Active false
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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

Yes
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

5efdd6a5-efb2-4f69-86d2-0f9ba6af1ed5
June 19, 2024
7
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 H98053055301S0
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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
Yes
No
No CLOSE

Customer Contact

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