AccessGUDID - DEVICE: Alatus (00851546007004)

GUDID

Device Identifier (DI) Information

Brand Name: Alatus
Version or Model: ALA-45 Unit Tray
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ALA-45
Company Name: RADIADYNE, L.L.C.

Primary DI Number: 00851546007004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005744772 *Terms of Use

Device Description: Alatus Vaginal Balloon Packing System Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
37468	Vaginal speculum, single-use	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 typically 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 to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical
JAQ	System, Applicator, Radionuclide, Remote-Controlled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092534	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4afb0d97-9885-4eb8-a113-734f27136882
Public Version Date: November 05, 2024
Public Version Number: 4
DI Record Publish Date: September 12, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10851546007001	5	00851546007004		In Commercial Distribution	Shelf Box
20851546007008	5	10851546007001		In Commercial Distribution	Shipper 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

[?]

Phone: 281-759-9600
Email: leahroe@radiadyne.com

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