AccessGUDID - DEVICE: White Pearl Preferred Angle ACP (B06221006200)

GUDID

Device Identifier (DI) Information

Brand Name: White Pearl Preferred Angle ACP
Version or Model: 2100-6200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2100-6200
Company Name: Osseus Fusion Systems, LLC

Primary DI Number: B06221006200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933442068 *Terms of Use

Device Description: PUNCH AWL, PREFERRED ACP

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):	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?
15275	Bone awl, reusable	A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	Appliance, Fixation, Spinal Intervertebral Body

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 44e734c7-2eaf-41ac-8c12-4e06a93219f4
Public Version Date: August 27, 2024
Public Version Number: 3
DI Record Publish Date: October 09, 2017