AccessGUDID - DEVICE: ROSCOE MEDICAL (00092237604014)

GUDID

Device Identifier (DI) Information

Brand Name: ROSCOE MEDICAL
Version or Model: IR-18
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00092237604014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: INVALID RING, 18 MOLDED FOAM

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):	Yes
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?
34981	Perineal/coccygeal cushion	A soft pillow or pad that is round or oval with a hole in its centre, intended to alleviate pressure on the caudal extremity of the vertebral column (coccyx) and/or perineal area. It is used when sitting to relieve pain from hemorrhoids or during recovery from surgery, pregnancy, or injury. The device is typically made of foam or an air inflatable vinyl or rubber.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRL	Cushion, Hemorrhoid

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1117cadb-0148-43ed-b776-13b8b2df8a62
Public Version Date: August 24, 2023
Public Version Number: 2
DI Record Publish Date: September 07, 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
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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-376-7263
Email: customerservice@compasshealthbrands.com

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

FDA TOOLS & RESOURCES