AccessGUDID - DEVICE: Gelfoam (10300090433045)

GUDID

Device Identifier (DI) Information

Brand Name: Gelfoam
Version or Model: 1 g Powder
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PHARMACIA & UPJOHN COMPANY LLC

Primary DI Number: 10300090433045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618054084 *Terms of Use

Device Description: Absorbable Hemostatic Powder, 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: Approximately 1.2 g actual fill weight
Weight: 1 Gram

Device Record Status

Public Device Record Key: ff9a68c9-ad89-445b-800f-84ffe4411cab
Public Version Date: December 17, 2020
Public Version Number: 6
DI Record Publish Date: September 01, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00300090433048	6	10300090433045		In Commercial Distribution	Carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(484)865-6166
Email: UDICompliance@pfizer.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES