Straumann SocketPlug - Carbonate Apatite Plug 10mm x 20mm - COLLAGEN MATRIX, INC.

Duns Number:176262442

Device Description: Carbonate Apatite Plug 10mm x 20mm

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More Product Details

Catalog Number

-

Brand Name

Straumann SocketPlug

Version/Model Number

070.051

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Device Record Status

Public Device Record Key

798689c3-6326-48ad-b025-1a797a789b4a

Public Version Date

April 18, 2022

Public Version Number

1

DI Record Publish Date

April 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COLLAGEN MATRIX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 457
U Unclassified 14