DEVICE: ProMax™ Series Bard® Max-Blade™ Coagulating Resector (00801741018497)

Device Identifier (DI) Information

ProMax™ Series Bard® Max-Blade™ Coagulating Resector
355215
In Commercial Distribution
355215
C. R. Bard, Inc.
00801741018497
GS1

1
016898496 *Terms of Use
ProMax™ Series Bard® Max-Blade™ Coagulating Resector, Resectoscope Compatibility: Storz Single Stem 27 Fr.
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
Endoscopic electrosurgical electrode, bipolar, single-use, sterile A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FAS ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
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

c8b2820b-4c8f-459d-9af0-7140132d36ea
June 26, 2018
3
July 23, 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
10801741018494 5 00801741018497 In Commercial Distribution CA
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)526-4455
medical.services@crbard.com
CLOSE