AccessGUDID - DEVICE: BEE Cage (04251631403524)

GUDID

Device Identifier (DI) Information

Brand Name: BEE Cage
Version or Model: Cervical 9x16 mm 8°
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B916L8
Company Name: NGMedical GmbH

Primary DI Number: 04251631403524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342615118 *Terms of Use

Device Description: BEE Cages were especially adapted to the local anatomy to secure the surgical outcome at the best. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The cage disposes of 4 pins on both bone facing surfaces, which serve the primary fixation. BEE implants are made of titanium alloy (Ti6Al4V) according to ASTM F 3001. BEE Cages are produced with selective laser melting (SLM) technique. It is not allowed to use BEE implants in contact with components of other manufacturers with the exception of bone graft substitutes or fillers.

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

[?]

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
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200429	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: 9x16 mm 8°

Device Record Status

Public Device Record Key: 1b273c85-1e7f-4aa4-9c13-0902f2153f99
Public Version Date: August 17, 2022
Public Version Number: 1
DI Record Publish Date: August 09, 2022