AccessGUDID - DEVICE: Coral (10889981110239)

GUDID

Device Identifier (DI) Information

Brand Name: Coral
Version or Model: 18-18-0400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-18-0400
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981110239
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: CoCr Str. Rod 5.5 x 400

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?
65116	Bone-screw internal spinal fixation system rod	An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNH	Orthosis, spondylolisthesis spinal fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091266	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
Device Size Text, specify: 5.5 x 400

Device Record Status

Public Device Record Key: 07012301-f781-448c-b9fd-9f44bafdb55e
Public Version Date: December 30, 2024
Public Version Number: 5
DI Record Publish Date: March 31, 2016

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(760)727-8399
Email: custsvcspine@seaspine.com

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