AccessGUDID - DEVICE: Barricaid® ACD Impactor (M906BARIMPACTOR0)

GUDID

Device Identifier (DI) Information

Brand Name: Barricaid® ACD Impactor
Version or Model: 400906-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BAR-IMPACTOR
Company Name: INTRINSIC THERAPEUTICS, INC.

Primary DI Number: M906BARIMPACTOR0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 105722131 *Terms of Use

Device Description: Single-use disposable surgical instrument to aid in insertion of the Barricaid® Annular Closure Device (ACD), in the event that additional impaction is necessary.

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:	Yes
Prescription Use (Rx):	No
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?
64237	Orthopaedic inorganic implant inserter/extractor, single-use	A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: cfbf320c-5c94-4703-9653-69f5294c07a7
Public Version Date: September 11, 2024
Public Version Number: 2
DI Record Publish Date: February 04, 2020