AccessGUDID - DEVICE: Nella NuSpec (00860000270427)

GUDID

Device Identifier (DI) Information

Brand Name: Nella NuSpec
Version or Model: NU001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CEEK WOMEN'S HEALTH

Primary DI Number: 00860000270427
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116951931 *Terms of Use

Device Description: Reusable Vaginal Speculum

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:	No
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?
35352	Vaginal speculum, reusable	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIB	Speculum, Vaginal, Nonmetal

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
Hydrogen Peroxide
High-level Disinfectant

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: d7eb014c-15e5-4ccc-9d5a-b90a06f39405
Public Version Date: May 23, 2023
Public Version Number: 3
DI Record Publish Date: August 18, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10860000270424	10	00860000270427		In Commercial Distribution	box of 10

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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 3158577219
Email: tbennett@ceekwomenshealth.com

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

FDA TOOLS & RESOURCES