AccessGUDID - DEVICE: Antalgic Trak (00860000487504)

GUDID

Device Identifier (DI) Information

Brand Name: Antalgic Trak
Version or Model: AT1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANTALGIC-TRAK

Primary DI Number: 00860000487504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043600853 *Terms of Use

Device Description: Power Traction Equipment

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:	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?
14105	Static powered traction system	An assembly of devices designed to apply continuous traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It usually consists of a mains electricity (AC-powered) motor with a control unit to generate and regulate the mechanical forces, and a cord (e.g., braided nylon) clamped to harnesses to transmit the force. Adjustable spreader bars attached to the control unit may be used to vary the angle at which the cord applies traction. The assembly may be table/wall-mounted for horizontal cervical and lumbar traction, or vertical cervical traction. It is used to widen intervertebral spaces to treat prolapsed intervertebral disks and other disorders.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITH	Equipment, Traction, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042482	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: 6b98fe72-e203-443a-a1aa-f924906f7daf
Public Version Date: November 30, 2018
Public Version Number: 1
DI Record Publish Date: October 30, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00860000487511	1	00860000487504		In Commercial Distribution	Inner pack

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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

Customer Contact

[?]

Phone: 8007923575
Email: contact@antalgic-trak.com

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