AccessGUDID - DEVICE: OraFOAM™ (10381780508656)

GUDID

Device Identifier (DI) Information

Brand Name: OraFOAM™
Version or Model: ORAFOAM-PKG-18
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ORAFOAM-PKG-18
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780508656
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2022
Device Count: 18
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: OraFOAM™ Absorbable Collagen Hemostatic Sponge Contents: 1 sponge 1/2 in x 1 in (1.27 cm x 2.54 cm)

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?
47201	Collagen haemostatic agent, non-antimicrobial	A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LMF	Agent, absorbable hemostatic, collagen based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P850010	007

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: Avoid excessive heat and humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1/2" x 1"

Device Record Status

Public Device Record Key: ffa76314-2151-4a89-8c27-bf23a181b7cc
Public Version Date: December 19, 2023
Public Version Number: 6
DI Record Publish Date: February 04, 2019