TABOTAMP FIBRILLAR

Basic Information

• Brand Name: TABOTAMP FIBRILLAR
• Primary DI: 10705031005372
• Version / Model: 431963
• Catalog Number: 431963
• Company Name: ETHICON, LLC
• Labeler DUNS: 829465157
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-20
• Public Version: 7
• Public Version Date: 2019-08-09
• Public Version Status: Update
• Public Device Record Key: 33a908de-fb96-4673-80b3-886c112eaacd
• Distribution End Date: 2015-06-23

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMG	Agent, absorbable hemostatic, non-collagen based	General, Plastic Surgery	878.4490	3

GMDN Terms

Code	Name	Definition	Implantable	Status
38771	Plant polysaccharide haemostatic agent, bioabsorbable	A bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031005379	GS1	CASE	10	Not in Commercial Distribution	2015-06-19
Primary	10705031005372	GS1

Premarket Submissions

Submission Number	Supplement Number
N12159	032

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged
• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Resterilize