Cramer Orthogel

Basic Information

• Brand Name: Cramer Orthogel
• Primary DI: 00311960620703
• Version / Model: 061935
• Company Name: CRAMER PRODUCTS, INC.
• Labeler DUNS: 007138183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2018-10-01
• Public Version: 1
• Public Version Date: 2018-11-01
• Public Version Status: New
• Public Device Record Key: ab780ca4-d49d-49d1-b30c-ee095678831c

Device Description

Cramer Orthogel, Two 1/8" x 12" x 12" sheets, Dressing, Wound, Hydrogel W/Out Drug And/Or Biologic

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10311960620700	GS1	Master Carton	10	In Commercial Distribution
Primary	00311960620703	GS1
Unit of Use	20311960620707	GS1

Device Sizes

Type	Value	Unit	Text
Depth	0.125	Inch
Width	12	Inch
Length	12	Inch

Storage Conditions

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