BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length - BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm - TECRES SPA

Duns Number:435428396

Device Description: BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length with plastic handgrip intended fo BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin.

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More Product Details

Catalog Number

-

Brand Name

BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length

Version/Model Number

ASB0120

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

KIH

Product Code Name

Dispenser, Cement

Device Record Status

Public Device Record Key

9e9ea92e-5c59-47a3-85b6-38ab58134cf5

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECRES SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 52