DEVICE: Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient® (00888937012743)

Device Identifier (DI) Information

Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®
AD750-KE30
In Commercial Distribution

Coopersurgical, Inc.
00888937012743
GS1

1
801895244 *Terms of Use
Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®
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Device Characteristics

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

GMDN

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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?
58051 Uterine manipulator, single-use
A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
HEW Culdoscope (And Accessories)
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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
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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
No Device Sizes
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Device Record Status

e970f913-56e6-48b0-bf1f-9a277f881e5b
February 28, 2024
7
September 23, 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
20888937012747 3 00888937012743 In Commercial Distribution
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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

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No Customer Contact currently defined
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