AccessGUDID - DEVICE: Torosa (05708932470858)

GUDID

Device Identifier (DI) Information

Brand Name: Torosa
Version or Model: 450-1329
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 450-1329
Company Name: Coloplast A/S

Primary DI Number: 05708932470858
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: Saline Filled Testicular Prosthesis

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?
35277	Testicle prosthesis	A device formed in the shape of a testis intended to be implanted in the scrotum to provide the cosmetic appearance of a testicle. It has an aesthetic role and helps to prevent psychogenic sequelae. The device may be made of synthetic polymer (e.g., silicone rubber, or made of a silicone envelope filled with silicone oil), or it may be made of a metallic material.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FAF	Prosthesis, Testicular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020003	007

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
Special Storage Condition, Specify: Keep out of sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Large

Device Record Status

Public Device Record Key: 3aa5b872-af2e-4eaf-9aac-fa7b4e3deeec
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 21, 2014

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8002583476
Email: urology@coloplast.com

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