DEVICE: Instrument pouch (05051223004264)

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Device Identifier (DI) Information

Instrument pouch
PS4050
PS4050
PURPLE SURGICAL INTERNATIONAL LIMITED
05051223004264
GS1
1
The Instrument Pouch is used for securing instruments in a convenient housing close to the surgical site, minimising hand to hand transfer.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Instrument management bag, sterile A sterile flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HET Laparoscope, Gynecologic (And Accessories)
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 95mm width x 405 mm depth
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Device Status

In Commercial Distribution
September 17, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
55051223004269 100 35051223004265 In Commercial Distribution shipping carton
35051223004265 25 05051223004264 In Commercial Distribution inner
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+441923839333
mail@purplesurgical.com
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