AccessGUDID - DEVICE: Dall-Miles (07613327036497)

GUDID

Device Identifier (DI) Information

Brand Name: Dall-Miles
Version or Model: 6704-8-240
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6704-8-240
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327036497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Cable

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
66932	Orthopaedic bone cerclage cable	An implantable braided metallic cord intended to be tightened with a crimp-like component to form a loop or ring around a fractured bone and/or fixation plate as part of an orthopaedic 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
HRS	Plate, fixation, bone
LRN	Wire, surgical
LYT	FIXATION ACCESSORY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202016	000
K945294	000
K961283	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
Device Size Text, specify: Diameter: 2.0 Millimeter
Length: 750.0 Millimeter

Device Record Status

Public Device Record Key: 1a8e176e-6b83-4f3a-8a68-8cc12bbf00c7
Public Version Date: February 19, 2024
Public Version Number: 9
DI Record Publish Date: September 24, 2015