AccessGUDID - DEVICE: OSTEON II (08809324764436)

GUDID

Device Identifier (DI) Information

Brand Name: OSTEON II
Version or Model: DT7G2030200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DT7G2030200
Company Name: GENOSS CO., Ltd.

Primary DI Number: 08809324764436
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690083006 *Terms of Use

Device Description: Bone grafting material, Synthetic

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:	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?
16995	Intracardiac electrode	An electrical conductor designed for measuring the electrical activity of and/or to provide pacing signals to the interior of the heart; some electrodes are used to provide electric (e.g., radio-frequency) energy to ablate cardiac tissue. It is usually a very small electrode capable of detecting weak bioelectrical signals and/or to provide high electrical energy; it is typically located at or near the tip of cardiac [e.g., electrophysiology (EP), pacing, ablation] catheters. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LYC	Bone grafting material, synthetic

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 1 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Milliliter

Device Record Status

Public Device Record Key: 0b9cb1d6-4a62-403a-aad7-6c0817931d19
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 09, 2016

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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