DEVICE: CONFIDENCE SPINAL CEMENT SYSTEM (10705034209470)

Device Identifier (DI) Information

CONFIDENCE SPINAL CEMENT SYSTEM
283903415
In Commercial Distribution
283903415
Medos International Sàrl
10705034209470
GS1

1
482661753 *Terms of Use
CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 15G x 4 Inches
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
Hypodermic needle, single-use, sterile A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes, secondary medication sets, or phlebotomy equipment (e.g., blood collection adapters or holders) to prepare and administer fluids/medications/drugs to a patient and/or to withdraw(aspirate) fluids from a patient. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GAA NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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

3ccc72de-2ddd-4465-aef5-838f2a532dd1
March 29, 2018
2
December 31, 2016
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
No Package DIs found
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(800)255-2500
xx@xx.xx
CLOSE