AccessGUDID - DEVICE: Vaginal Applicator, 35mm (00858012005502)

GUDID

Device Identifier (DI) Information

Brand Name: Vaginal Applicator, 35mm
Version or Model: 720270
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AG3035
Company Name: Icad, Inc.

Primary DI Number: 00858012005502
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108870254 *Terms of Use

Device Description: Vaginal Applicator 35 mm

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:	No
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?
59684	Intraoperative/postoperative therapeutic x-ray system vaginal applicator	A non-sterile component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source when the system is used for intracavitary radiotherapy of the vagina. It is cylinder-shaped and may have an introduction-restricting guard. It is typically supplied in a range of sizes (diameters). This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAD	System, Therapeutic, X-Ray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072616	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: fa231ec7-df5d-4a1b-b002-03b4f7169a41
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 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
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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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