DEVICE: MICTEC DISSECTION SPATULA (B09920942100)

Device Identifier (DI) Information

MICTEC DISSECTION SPATULA
20942-10
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B09920942100
HIBCC
September 23, 2018
1
040729840 *Terms of Use
MICTEC DISSECTION SPATULA SEMI-SHARP CURVED UP
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Laparoscopic dissection spatula A rigid laparoscopic device designed for the blunt dissection of broadly implanted adhesions during a therapeutic laparoscopy. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GCJ Laparoscope, General & Plastic Surgery
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K002877 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

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

Clinically Relevant Size

[?]
Size Type Text
Length: 300 Millimeter
CLOSE

Device Record Status

b75d2090-41f5-4932-89e2-d7932d70b45f
August 27, 2018
4
September 30, 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
No
No
No CLOSE

Customer Contact

[?]
800-821-7496
info@sontecinstruments.com
CLOSE