DEVICE: nubert (05019829239961)
Device Identifier (DI) Information
nubert
24003
In Commercial Distribution
24003
VERNACARE LIMITED
24003
In Commercial Distribution
24003
VERNACARE LIMITED
Impervious, assymetric bag for the endoscopic retrieval of tissue. Volume 100 mL. Port size 10 mm.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45130 | 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GCJ | Laparoscope, general & plastic surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 25 Degrees Celsius |
Special Storage Condition, Specify: Keep dry and keep from sunlight |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 100 Milliliter |
Device Size Text, specify: Port size 10 mm |
Device Record Status
be29ca35-0517-423c-b0e1-e4674882369d
April 20, 2022
5
September 08, 2016
April 20, 2022
5
September 08, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05019829240035 | 10 | 05019829239961 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401204529494
Regulatory.Affairs@vernagroup.com
Regulatory.Affairs@vernagroup.com