AccessGUDID - DEVICE: RPM™ Reinforced PTFE Mesh (D765RPM200PST0)

GUDID

Device Identifier (DI) Information

Brand Name: RPM™ Reinforced PTFE Mesh
Version or Model: RPM200PST
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Osteogenics Biomedical Inc

Primary DI Number: D765RPM200PST0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 123853058 *Terms of Use

Device Description: RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.

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?
66253	Dental/maxillofacial surgical mesh, metal/polymer	A non-bioabsorbable, implantable, woven/knitted porous material made of both a synthetic polymer(s) and metal (typically a synthetic polymer covered metal frame) intended to provide temporary stabilization and support to a bone graft in the alveolar ridges, maxilla, or mandible. It is typically placed between the bone graft and soft tissue during dental or maxillofacial reconstruction and augmentation surgical procedures. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPK	Barrier, Synthetic, Intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171774	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 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 36 Millimeter
Width: 25 Millimeter

Device Record Status

Public Device Record Key: 2dbcd4ff-aacd-423f-8e9d-8c0229c7c27e
Public Version Date: January 30, 2024
Public Version Number: 2
DI Record Publish Date: July 27, 2020