AccessGUDID - DEVICE: Cramer Orthogel (00311960620727)

GUDID

Device Identifier (DI) Information

Brand Name: Cramer Orthogel
Version or Model: 061940
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CRAMER PRODUCTS, INC.

Primary DI Number: 00311960620727
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 007138183 *Terms of Use

Device Description: Cramer Orthogel, Two 3/8" x 12" x 12" sheets, Dressing, Wound, Hydrogel W/Out Drug And/Or Biologic

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):	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?
47763	Wound hydrogel dressing, non-sterile	A non-sterile wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids/gases. Some types are intended to reduce hypertrophic/keloid scars by providing a barrier impermeable to liquids/gases to maintain a moist environment. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic

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
Special Storage Condition, Specify: Keep out of reach of children.

Clinically Relevant Size

[?]

Size Type Text
Depth: 0.375 Inch
Width: 12 Inch
Length: 12 Inch

Device Record Status

Public Device Record Key: bb3f2df3-668a-46e3-8646-f5f7e6bc662b
Public Version Date: November 01, 2018
Public Version Number: 1
DI Record Publish Date: October 01, 2018