DEVICE: Ultimate Endo Retrieval pouch (05051223022374)
Device Identifier (DI) Information
Ultimate Endo Retrieval pouch
PS3442ULT
In Commercial Distribution
PS3442ULT
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3442ULT
In Commercial Distribution
PS3442ULT
PURPLE SURGICAL INTERNATIONAL LIMITED
The Ultimate Endo Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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 |
---|---|
KGY | Bag, Intestine |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 145 Millimeter |
Width: 90 Millimeter |
Total Volume: 250 Milliliter |
Device Record Status
a6891791-20b6-4560-be47-1b7eea6f495d
March 29, 2018
2
September 17, 2016
March 29, 2018
2
September 17, 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 |
---|---|---|---|---|---|
55051223022379 | 50 | 35051223022375 | In Commercial Distribution | shipping carton | |
35051223022375 | 5 | 05051223022374 | In Commercial Distribution | shelf box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+441923839333
mail@purplesurgical.com
mail@purplesurgical.com