AccessGUDID - DEVICE: SONICFUSION (07613327096019)

GUDID

Device Identifier (DI) Information

Brand Name: SONICFUSION
Version or Model: 1910-1001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1910-1001
Company Name: Stryker Trauma SA

Primary DI Number: 07613327096019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481999654 *Terms of Use

Device Description: Handpiece

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45885	Bone pin ultrasonic osteosynthesis system handpiece	A hand-held, pen-like device intended to convert high frequency electrical current into high frequency mechanical oscillation (ultrasonic vibration) used in a bone pin ultrasonic osteosynthesis system designed to briefly melt (weld) a bioabsorbable fixation pin in a surgically pre-drilled bone hole to allow its fusion and anchoring within the bone (osseointegration), and enable its bonding with a fixation plate used for internal fixation (osteosynthesis). This device holds a dedicated detachable sonotrode tip at the distal end and the power switch is operated through a foot-pedal connected to the generator for allowing the surgeon to control the welding process. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTY	PIN, FIXATION, SMOOTH
GAT	Suture, nonabsorbable, synthetic, polyethylene
MAI	Fastener, fixation, biodegradable, soft tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef678cc1-11bd-4326-a778-ffd2bceb55f7
Public Version Date: June 19, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016

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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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