DEVICE: CODMAN MALIS MODULE 1000 (20886704039966)

Device Identifier (DI) Information

CODMAN MALIS MODULE 1000
80-9104
Not in Commercial Distribution
809104
CODMAN & SHURTLEFF, INC.
20886704039966
GS1
September 28, 2017
10
607846297 *Terms of Use
CODMAN MALIS MODULE 1000 Integrated Tubing and Unitized Bipolar Cord Set
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
Electrical-only medical device connection cable, single-use A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.
Surgical irrigation tubing set, single-use A collection of sterile, flexible, single-bore, external tubing intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline solution) from its source (e.g., gravity feed bag, feed pump) to a site of surgical intervention and/or endoscopy; it is not intended to navigate through an anatomical lumen. The tubing typically includes associated items such as clamps, filters, spikes, and connectors; it may include a syringe or an integrated manual pump (e.g., a squeeze bulb). It does not include suction tubing and is not intended to aspirate the surgical/endoscopic site (i.e., not an irrigation/aspiration tubing set). This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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
Special Storage Condition, Specify: Waste Electrical and Electronic Equipment
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

59a5781d-4e84-41f4-834d-d4f66e7243fc
May 08, 2018
3
June 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: 10886704039969 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