AccessGUDID - DEVICE: BEE PLIF Cage (04251631409496)

GUDID

Device Identifier (DI) Information

Brand Name: BEE PLIF Cage
Version or Model: 11 x 30 mm 18°
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BLP1130L18
Company Name: NGMedical GmbH

Primary DI Number: 04251631409496
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342615118 *Terms of Use

Device Description: BEE®PLIF cages have been specially adapted to suit the local anatomy to ensure the operative outcome to the greatest extent possible. BEE®PLIF cages are made of titanium alloy in accordance with ASTM F3001 and are produced in an additive manufacturing process. The implants are available in various heights, lengths and lordosis angles. The cranial and caudal side of the implant is rough to achieve a good degree of anchoring of the implant.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38161	Metallic spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

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 [?]
K211413	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 11 x 30 mm 18°

Device Record Status

Public Device Record Key: 6c491f46-72aa-46d0-b5f3-676d4be42083
Public Version Date: August 11, 2022
Public Version Number: 1
DI Record Publish Date: August 03, 2022