AccessGUDID - DEVICE: Dall-Miles (07613327036336)

GUDID

Device Identifier (DI) Information

Brand Name: Dall-Miles
Version or Model: 3704-0-040
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3704-0-040
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327036336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Beaded Cable and Sleeve Set

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:	Yes
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
LYT	FIXATION ACCESSORY
LRN	Wire, surgical
HRS	Plate, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202016	000
K971741	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: 1.6 Millimeter

Device Record Status

Public Device Record Key: 0e3551b1-d215-4676-a956-71d79b45784e
Public Version Date: February 19, 2024
Public Version Number: 8
DI Record Publish Date: September 24, 2015