AccessGUDID - DEVICE: SeaSpine Expandable Interbody (10889981123727)

GUDID

Device Identifier (DI) Information

Brand Name: SeaSpine Expandable Interbody
Version or Model: 98-2112
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 98-2112
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981123727
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: 12mm Trial (22x10mm, 0 deg)

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:	Yes
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
MAX	Intervertebral fusion device with bone graft, lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133418	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: 12mm (22x10mm, 0 Deg)

Device Record Status

Public Device Record Key: 414b1050-4ba3-4c9a-b00c-fb75dee80d55
Public Version Date: December 30, 2024
Public Version Number: 8
DI Record Publish Date: May 12, 2017