AccessGUDID - DEVICE: Gynex (GYNX290651)

GUDID

Device Identifier (DI) Information

Brand Name: Gynex
Version or Model: 29065
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GYNEX CORPORATION

Primary DI Number: GYNX290651
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 012997685 *Terms of Use

Device Description: No description.

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):	No
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?
61479	Intrauterine device thread scissors	A sterile, hand-held manual instrument designed to cut the thread(s) of an in situ intrauterine device (IUD) to an appropriate length for extraction of the device. It is comprised of two pivoted blades which cut with a shearing action, operated using finger and thumb ring-handles. It is made of plastic materials sometimes with metal blades; it is available in different forms (e.g., with in-line or lateral blades). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRW	Scissors, General, Surgical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

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

Public Device Record Key: d305bb22-a618-4eae-a7d0-4b112a653b0e
Public Version Date: December 21, 2023
Public Version Number: 1
DI Record Publish Date: December 13, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: GYNX290650 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES