DEVICE: Ridge Preservation Kit - Cytoplast Technique (D765KITRPCT0)

Device Identifier (DI) Information

Ridge Preservation Kit - Cytoplast Technique
KITRPCT
In Commercial Distribution

Osteogenics Biomedical Inc
D765KITRPCT0
HIBCC

1
123853058 *Terms of Use
Ridge Preservation Kit - Cytoplast Technique; Includes: 1 sterile nonresorbable PTFE monofilament suture (model CS0518K) - USP 3-0, 18" length,16 mm 3/8 reverse cutting needle, 1 sterile nonresorbable PTFE membrane, textured (model TXT1224K) - 12 mm x 24 mm, 1 sterile GBM allograft (model C73050K) - 70% mineralized cortical bone matrix & 30% demineralized bone matrix
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45148 Dental/maxillofacial surgical procedure kit, non-medicated, single-use
A collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

02eb3dde-ccae-4fbd-9aa1-5df8263a596a
May 07, 2019
3
November 20, 2017
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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