AccessGUDID - DEVICE: XEROFORM PETROLATUM (10381780471325)

GUDID

Device Identifier (DI) Information

Brand Name: XEROFORM PETROLATUM
Version or Model: 71164
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DKC71164
Company Name: Derma Sciences Canada Inc

Primary DI Number: 10381780471325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 200564891 *Terms of Use

Device Description: Petrolatum Dressing. Fine Mesh Gauze Impregnated with 3% Bismuth Tribromophenate in a Petrolatum Blend.

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":	Yes
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?
48132	Petrolatum woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates; it is not however a dedicated burn dressing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GER	GAUZE, EXTERNAL (WITH DRUG/BIOLOGIC/ANIMAL SOURCE MATERIAL)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Do not use if package is damaged

Clinically Relevant Size

[?]

Size Type Text
Width: 2 Inch
Length: 5 Centimeter
Length: 2 Inch
Width: 5 Centimeter

Device Record Status

Public Device Record Key: 784a787d-fee7-4ab0-bf8f-59211302b637
Public Version Date: June 25, 2024
Public Version Number: 4
DI Record Publish Date: September 13, 2018