AccessGUDID - DEVICE: Gelfoam (10300090353015)

GUDID

Device Identifier (DI) Information

Brand Name: Gelfoam
Version or Model: Size 100 - Compressed
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHARMACIA & UPJOHN COMPANY LLC

Primary DI Number: 10300090353015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618054084 *Terms of Use

Device Description: Absorbable Hemostatic Sponge, Collagen Based

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	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 [?]
N18286	017
N18286	018
N18286	020
N18286	021
N18286	023
N18286	024
N18286	025
N18286	026

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: See USP Controlled Room Temperature
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 mm compressed to 2.5 mm
Width: 80 Millimeter
Length: 125 Millimeter
Height: 2.5 Millimeter

Device Record Status

Public Device Record Key: 60359e45-0fe9-46a3-b2a5-c730b157fe8d
Public Version Date: December 17, 2020
Public Version Number: 6
DI Record Publish Date: September 01, 2014