N/A - STIRRUP CURETTE, STRAIGHT, FLAT - HYHTE HOLDINGS, INC.

Duns Number:073029645

Device Description: STIRRUP CURETTE, STRAIGHT, FLAT

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More Product Details

Catalog Number

GZB15S202

Brand Name

N/A

Version/Model Number

GZB15S202

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

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

da3ca0fc-8ba7-4f02-b36d-87ccde71eb7d

Public Version Date

July 21, 2021

Public Version Number

1

DI Record Publish Date

July 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HYHTE HOLDINGS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 80
2 A medical device with a moderate to high risk that requires special controls. 12769