AccessGUDID - DEVICE: NA (20887587048946)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 413.592
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 413592
Company Name: Synthes GmbH

Primary DI Number: 20887587048946
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: 3.0MM TI LOCKING SCREW 22MM FOR STERNAL LOCKING PLATES

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:	Yes
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?
34017	Sternal fixation device	A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDQ	CERCLAGE, FIXATION
HRS	PLATE, FIXATION, BONE
HWC	Screw, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010943	000
K093772	000

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: 24f1581a-d2ea-4588-9d02-13093e9c1980
Public Version Date: April 25, 2022
Public Version Number: 4
DI Record Publish Date: September 14, 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
HIBCC	H9804135920

Unit of Use DI

[?]

Unit of Use DI Number: 80887587048948 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

[?]

Phone: +1(800)255-2500
Email: xx@xx.xx

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