AccessGUDID - DEVICE: Dakota ACDF System (00840019942102)

GUDID

Device Identifier (DI) Information

Brand Name: Dakota ACDF System
Version or Model: 71-BK-0103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71-BK-0103
Company Name: PRECISION SPINE, INC.

Primary DI Number: 00840019942102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079398589 *Terms of Use

Device Description: 18 x 15 7° Implant Kit

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?
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203129	000

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: e2ef61c5-fe75-4e37-848a-caec06a72f87
Public Version Date: June 16, 2021
Public Version Number: 1
DI Record Publish Date: June 08, 2021

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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