AccessGUDID - DEVICE: TABOTAMP FIBRILLAR (10705031005372)

GUDID

Device Identifier (DI) Information

Brand Name: TABOTAMP FIBRILLAR
Version or Model: 431963
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 431963
Company Name: ETHICON, LLC

Primary DI Number: 10705031005372
Issuing Agency: GS1
Commercial Distribution End Date: June 23, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 829465157 *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):	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?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LMG	Agent, absorbable hemostatic, non-collagen based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
N12159	032

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 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Do not use if package is damaged
Special Storage Condition, Specify: Do Not Resterilize

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33a908de-fb96-4673-80b3-886c112eaacd
Public Version Date: August 09, 2019
Public Version Number: 7
DI Record Publish Date: September 20, 2014