ELMED - 5MM DIA., 36 CM, HUNTER BOWEL GRASPER, 40 MM JAW, - ELMED INCORPORATED

Duns Number:049290364

Device Description: 5MM DIA., 36 CM, HUNTER BOWEL GRASPER, 40 MM JAW, FENESTRATED JAW W/ DEBAKEY-TYPE TEETH FO 5MM DIA., 36 CM, HUNTER BOWEL GRASPER, 40 MM JAW, FENESTRATED JAW W/ DEBAKEY-TYPE TEETH FOR ATRAUMATIC MANIPULATION OF DELICATE TISSUE E.G. BOWEL, STOMACH; DOUBLE-ACTION, INSULATED SHAFT, SLIDE-LOCK HANDLE, ROTATABLE ONE-PIECE (B)

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More Product Details

Catalog Number

52636-159B

Brand Name

ELMED

Version/Model Number

52636-159B

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

-

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

033e621a-8632-44c6-ace9-b60faeea8fea

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELMED INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 4068