AccessGUDID - DEVICE: SURGIFLO® Hemostatic Matrix Kit with Thrombin (15712123000325)

GUDID

Device Identifier (DI) Information

Brand Name: SURGIFLO® Hemostatic Matrix Kit with Thrombin
Version or Model: 2993
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Ferrosan Medical Devices A/S

Primary DI Number: 15712123000325
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 305175344 *Terms of Use

Device Description: No description.

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
LMF	Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990004	008
P990004	016
P990004	017
P990004	018
P990004	019
P990004	022

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
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 963cec92-60d4-4dfd-99ae-8216d5262e64
Public Version Date: August 08, 2018
Public Version Number: 4
DI Record Publish Date: September 20, 2014