AccessGUDID - DEVICE: Injector (M803TMI1162)

GUDID

Device Identifier (DI) Information

Brand Name: Injector
Version or Model: EZ Inject HF SHG Catheter
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TMI1162
Company Name: MEDGYN PRODUCTS, INC.

Primary DI Number: M803TMI1162
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103913430 *Terms of Use

Device Description: EZ Inject HF SHG Catheter

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	No
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?
15622	Uterine injector	A hand-held manual device designed to inject/administer liquids into the uterus and/or fallopian tubes, typically contrast medium during radiographic procedures to evaluate tubal patency. It is typically used in conjunction with an appropriate intrauterine catheter which may be manipulated through an external mechanism. The injector may be used to manipulate or reposition the uterus during diagnostic and/or surgical procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKF	Cannula, Manipulator/Injector, Uterine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032835	000

Device Exempt from Premarket Submission: No 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: 32b3ded0-2e94-45b9-9dbe-5b5f33e43a2a
Public Version Date: June 27, 2022
Public Version Number: 1
DI Record Publish Date: June 17, 2022

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: No Unit of Use DI Numbers Found 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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