DEVICE: ETHICON (10705031005082)

Device Identifier (DI) Information

ETHICON
3909
In Commercial Distribution
3909
ETHICON INC.
10705031005082
GS1

1
002144145 *Terms of Use
EVICEL 45CM FLEXIBLE TIP (SET OF 3)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Haematological concentrate system applicator, open-surgery A sterile, manually-operated component of a haematological concentrate system designed to administer, in a liquid or spray form, a haematological concentrate typically made at the point-of-care with the patient's own blood/bone marrow, or other blood products (e.g., platelet concentrate, bone marrow aspirate concentrate, thrombin), to an open surgical wound or graft to facilitate haemostasis and healing. The device may have one channel to administer one product, or two channels to co-administer two different products simultaneously in a precise ratio. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FMF Syringe, piston
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

20aedfb2-57bd-474c-bef2-1ced789bf9a3
March 29, 2018
2
September 23, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20705031005089 3 10705031005082 In Commercial Distribution BOX
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)384-4266
xxx@xxx.xxx
CLOSE