AccessGUDID - DEVICE: Extentrac Elite (B727M100)

GUDID

Device Identifier (DI) Information

Brand Name: Extentrac Elite
Version or Model: M100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Advanced Back Technologies Inc

Primary DI Number: B727M100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070462820 *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:	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?
61867	Programmable powered traction system	An assembly of devices intended to generate and apply computer-controlled horizontal cervical and/or lumbar traction distraction forces, with the ability to target specific spinal segments, for non-surgical decompression of intervertebral discs and/or widening of intervertebral spaces to treat prolapsed intervertebral discs and related disorders. It typically consists of a mains electricity (AC-powered) motor with a computerized control unit to generate and regulate the mechanical forces, an adjustable table and attachments (e.g., cord or pulley) to transmit traction forces to the harnesses and/or the table, with ability to tilt a portion of the table to adjust distraction force vectors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITH	Equipment, Traction, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031996	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: b22666e4-2057-492b-aa6c-8dea1c04285f
Public Version Date: June 15, 2023
Public Version Number: 3
DI Record Publish Date: November 06, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: Yes
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: +16314785726
Email: extentrac.info@gmail.com

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