AccessGUDID - DEVICE: ORCA Foam (00860003109915)

GUDID

Device Identifier (DI) Information

Brand Name: ORCA Foam
Version or Model: Standard
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Orca Products, LLC

Primary DI Number: 00860003109915
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2023
Device Count: 50
Labeler D-U-N-S® Number*: 117716283 *Terms of Use

Device Description: AbsorbaleGelatin Sponge

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):	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?
48170	Gelatin haemostatic agent	A sterile, bioabsorbable device derived from animal gelatin (typically pork skin gelatin) that is intended to be applied to surgical and traumatic wounds to facilitate local haemostasis through its high blood-absorbing capacity; it does not contain an antimicrobial agent. It is typically in the form of a pad/sponge and has no intrinsic haemostatic action but induces haemostasis through its intensely porous structure which enables it to absorb many times its weight in blood; the device is intended to remain in the wound to be absorbed by the body. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LYA	Splint, Intranasal Septal
KHJ	Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060878	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c470ab0-aece-4e6c-80ae-562cabe0e902
Public Version Date: September 07, 2023
Public Version Number: 2
DI Record Publish Date: December 15, 2020