AccessGUDID - DEVICE: NA (00889024035546)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 1191-48
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00-1191-048-00
Company Name: Zimmer, Inc.

Primary DI Number: 00889024035546
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2023
Device Count: 6
Labeler D-U-N-S® Number*: 056038268 *Terms of Use

Device Description: No description.

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?
66933	Orthopaedic bone cerclage wire	An implantable thin metallic cord intended to be tightened with a knot to form a loop or ring around a fractured orthopaedic bone and/or stabilize an implant (typically a fixation plate) for treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDQ	CERCLAGE, FIXATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150889	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
Length: 24 Inch
Device Size Text, specify: USP Size 10, Metric Size 12, B&S 16 Ga., 0.048 Inch, Diameter

Device Record Status

Public Device Record Key: d4ee076d-6b0d-43f8-930c-025e0b4a4784
Public Version Date: February 19, 2024
Public Version Number: 6
DI Record Publish Date: September 26, 2017