Transfer Impression Coping - Biotem AR TRANSFER IMPRESSION COPING(HEX) - Inosys, Inc.

Duns Number:101803383

Device Description: Biotem AR TRANSFER IMPRESSION COPING(HEX) Ø4.0-11mm for mini

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More Product Details

Catalog Number

-

Brand Name

Transfer Impression Coping

Version/Model Number

PBIT M40SH

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)

-

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

4541c68b-c1db-4224-832f-52cb28ddf88b

Public Version Date

June 23, 2022

Public Version Number

1

DI Record Publish Date

June 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INOSYS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 146