AccessGUDID - DEVICE: Baha (09321502038379)

GUDID

Device Identifier (DI) Information

Brand Name: Baha
Version or Model: 91052
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 91052
Company Name: Cochlear Bone Anchored Solutions AB

Primary DI Number: 09321502038379
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559784736 *Terms of Use

Device Description: Osscora Surgical Set 230 V (Asia Pacific)

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?
42164	Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEY	MOTOR, SURGICAL INSTRUMENT, AC-POWERED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 8 and 80 Percent (%) Relative Humidity
Handling Environment Humidity: between 8 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 914944f1-8256-4dae-b168-590fb6fea411
Public Version Date: November 21, 2023
Public Version Number: 3
DI Record Publish Date: July 03, 2017

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)523-5798
Email: customer@cochlear.com

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