DEVICE: Retrieval Pouch (Multi Deploy) 12mm (B354OSRP120)

Download: XML | JSON

Device Identifier (DI) Information

Retrieval Pouch (Multi Deploy) 12mm
OS-RP-12
OS-RP-12
ORANGE SURGICAL INSTRUMENTS, LLC
B354OSRP120
HIBCC
1
Retrieval Pouch (Multi Deploy) 12mm
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
Tissue extraction bag An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.
Endoscopic electrosurgical electrode, monopolar, single-use A sterile, invasive, distal component of an electrosurgical system intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is a long thin device 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 with any form of 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
GCJ Laparoscope, General & Plastic Surgery
GEI Electrosurgical, Cutting & Coagulation & Accessories
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 Status

In Commercial Distribution
November 07, 2016
November 07, 2019
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
B354OSRP1210 10 B354OSRP120 2019-11-07 In Commercial Distribution
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

[?]
No Customer Contact currently defined
CLOSE