AccessGUDID - DEVICE: BIA310 Implant 4 mm with 14mm abutment (09321502043908)

GUDID

Device Identifier (DI) Information

Brand Name: BIA310 Implant 4 mm with 14mm abutment
Version or Model: P1340893
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P1340893
Company Name: Cochlear Bone Anchored Solutions AB

Primary DI Number: 09321502043908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559784736 *Terms of Use

Device Description: N/A

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
46638	Craniofacial bone screw, non-bioabsorbable	A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MAH	Hearing aid, bone conduction, implanted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182116	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Implant 4 mm with 14 mm Abutment
Length: 14 Millimeter

Device Record Status

Public Device Record Key: 0ce7134a-66db-4af1-aa03-3e93805a7b58
Public Version Date: June 19, 2024
Public Version Number: 4
DI Record Publish Date: May 22, 2019