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

GUDID

Device Identifier (DI) Information

Brand Name: Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®
Version or Model: AD750-KE30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Coopersurgical, Inc.

Primary DI Number: 00888937012743
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801895244 *Terms of Use

Device Description: Advincula Delineator™ Uterine Manipulator with 3.0 cm Ultem® Koh-Efficient®

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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

[?]

FDA Product Code

Product Code	Product Code Name
HEW	Culdoscope (And Accessories)

[?]

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Sterilization

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

Storage and Handling
No storage/handling found

[?]

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20888937012747	3	00888937012743		In Commercial Distribution

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Customer Contact

[?]

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

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact