AccessGUDID - DEVICE: OSTEO-MESH TM-300 (D765TM454510)

GUDID

Device Identifier (DI) Information

Brand Name: OSTEO-MESH TM-300
Version or Model: TM4545
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Osteogenics Biomedical Inc

Primary DI Number: D765TM454510
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 123853058 *Terms of Use

Device Description: Titanium Ridge Augmentation Mesh, 45mm x 45mm, Nonsterile, Contents: 1 Mesh

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
48004	Dental bone matrix implant, metallic	A sterile non-bioabsorbable device made of metal and/or metal oxide [e.g., titanium (Ti)] implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically available as porous granules.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JEY	Plate, Bone

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 45 Millimeter
Width: 45 Millimeter

Device Record Status

Public Device Record Key: 5653960d-9b8f-45bc-a6d9-271c302b4ee4
Public Version Date: December 07, 2020
Public Version Number: 4
DI Record Publish Date: April 29, 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: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

No Customer Contact currently defined

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