AccessGUDID - DEVICE: Ballista™ Percutaneous (00888480214311)

GUDID

Device Identifier (DI) Information

Brand Name: Ballista™ Percutaneous
Version or Model: 2000-6904
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2000-6904
Company Name: BIOMET SPINE LLC

Primary DI Number: 00888480214311
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018577570 *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:	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?
61235	Cannulated surgical drill bit, single-use	A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNI	Orthosis, spinal pedicle fixation
KWQ	Appliance, fixation, spinal intervertebral body
NKB	Thoracolumbosacral pedicle screw system
MNH	Orthosis, spondylolisthesis spinal fixation

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
Device Size Text, specify: BLUNT GUIDEWIRE 1.6MM X 510MM PEDICLE SCREW SYSTEM

Device Record Status

Public Device Record Key: c7f69f67-b8a7-4da0-8b1f-e71b88e02e28
Public Version Date: January 03, 2025
Public Version Number: 6
DI Record Publish Date: June 28, 2020

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: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)447-3625
Email: USBROCustomerService@zimmerbiomet.com

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