AccessGUDID - DEVICE: Mariner (10889981134556)

GUDID

Device Identifier (DI) Information

Brand Name: Mariner
Version or Model: 90-0231
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90-0231
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981134556
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: Head Inserter, Locking, 1/4 in sq

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?
12696	Orthopaedic inorganic implant inserter/extractor, reusable	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 reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160902	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: 1/4 in sq

Device Record Status

Public Device Record Key: 75e864a1-7352-498f-8c25-8c447ec5996d
Public Version Date: December 30, 2024
Public Version Number: 8
DI Record Publish Date: September 02, 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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