AccessGUDID - DEVICE: KerraPro (05060077230439)

GUDID

Device Identifier (DI) Information

Brand Name: KerraPro
Version or Model: 4 x 4 x 0.1 in
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KPRO10
Company Name: CRAWFORD HEALTHCARE LIMITED

Primary DI Number: 05060077230439
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 543740310 *Terms of Use

Device Description: No description.

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?
60470	Pressure-management bandage, silicone	A non-sterile piece of silicone material intended to be worn over pressure-point areas of the body to help prevent the development of, and/or treat, pressure and friction sores in patients with restricted mobility. It is available in various shapes (e.g.,, concave shapes for the heel or elbow, pads for the sacrum, and sheets or strips for other areas of the body) and sizes, and may be used in a healthcare facility or in the home. This is a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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
Depth: 0.1 Inch
Length: 4 Inch
Height: 4 Inch

Device Record Status

Public Device Record Key: a292876c-08f0-4c44-b5ee-2910a92ce009
Public Version Date: September 09, 2020
Public Version Number: 2
DI Record Publish Date: October 01, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05060077234093	32	05060077230385		In Commercial Distribution	Shipper
05060077230385	5	05060077230439		In Commercial Distribution	Carton

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: +4401565654920
Email: andrew.jackson@acelity.com

Phone: +4401565654920
Email: elizabeth.woods@acelity.com

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