RTMED - Shandong Haidike Medical Products Co., Ltd.

Duns Number:550402542

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

RTMED

Version/Model Number

4-0 75cm 3/8 Cutting 16mm

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

K212603

Product Code Details

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Device Record Status

Public Device Record Key

e5226b6c-8857-4465-9dc7-c8fb06365746

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 43