GELPI RETRACTOR - GELPI 1ST GENERATION RETRACTOR DEEP ANGLED TIPS - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: GELPI 1ST GENERATION RETRACTOR DEEP ANGLED TIPS ENCLOSED RATCHET

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More Product Details

Catalog Number

-

Brand Name

GELPI RETRACTOR

Version/Model Number

1100-629GR

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"

Yes

For Single-Use

-

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

GAD

Product Code Name

RETRACTOR

Device Record Status

Public Device Record Key

f826a30b-bad7-46ae-b0f6-e9c52704f39d

Public Version Date

March 31, 2020

Public Version Number

1

DI Record Publish Date

March 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414