AccessGUDID - DEVICE: NA (10886982258724)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 04.231.022S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04231022S
Company Name: Synthes GmbH

Primary DI Number: 10886982258724
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486711679 *Terms of Use

Device Description: 5.0MM TI VA POSITIONING PIN STERILE

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?
67083	Orthopaedic fixation plate cerclage pin/eye	A small implantable device designed to facilitate implantation of an orthopaedic fixation plate using cerclage cable or wire, whereby it attaches to the plate and/or underlying bone and provides a hole (eye) through which the cerclage cable is threaded. The pin portion may be one of a variety of designs which may be: 1) threaded into plate hole; 2) seated within a plate hole and inserted into the underlying bone; or 3) inserted into the drive hole of an appropriate screw head. It is used for plate fixation when screws are not an option. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JDQ	Cerclage, fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162124	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: fe56ca54-6150-458c-8748-f3ed3d8f1db8
Public Version Date: February 27, 2024
Public Version Number: 4
DI Record Publish Date: October 21, 2019

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	H67904231022S0

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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