AccessGUDID - DEVICE: Integra® Miltex® (10381780168980)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 015-99612
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 015-99612
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780168980
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 100
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integrator™ Chiropractic Adjustment Instrument - Tips Only, White - 100 Pack

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":	Yes
For Single-Use:	No
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?
63426	Joint/spinal manipulator, mechanical	A hand-held, non-electric, mechanically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. The instrument uses a manually-operated, mechanical, plunger-like mechanism (e.g., spring-loaded) to deliver thrust to the patient's body via its rounded distal end (e.g., rubber-tipped stylus); it typically has two or more force settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXM	MANIPULATOR, PLUNGER-LIKE JOINT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K950646	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: cf5eb7f4-7f13-4d4e-a02e-b6a8664d9b83
Public Version Date: July 01, 2020
Public Version Number: 4
DI Record Publish Date: September 12, 2018