AccessGUDID - DEVICE: LUMINELLE Aspirator (00853277008107)

GUDID

Device Identifier (DI) Information

Brand Name: LUMINELLE Aspirator
Version or Model: LUM-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20081
Company Name: UVISION 360, INC.

Primary DI Number: 00853277008107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080826327 *Terms of Use

Device Description: LUMINELLE Aspirator

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":	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?
16227	Endocervical aspirator	A collection of devices designed to remove superficial tissue from the mucous membrane lining the cervical canal (endometrium) through manually-powered suction. It typically includes a slender endocervical curette, a syringe, a bulb, and a pipette. The device is used in obstetrics, gynaecology, surgery, oncology, histology, fertility studies, and cancer screening (cervical carcinoma); it is also used after colposcopy and to aid fertility by removing the mucus plug from the cervix.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QFZ	Gastroenterology-Urology Accessories To A Biopsy Instrument

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f10ff3ab-ae96-4a08-81a1-36f3c4790030
Public Version Date: March 08, 2024
Public Version Number: 1
DI Record Publish Date: February 29, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10853277008104	5	00853277008107		In Commercial Distribution	Box

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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