AccessGUDID - DEVICE: Stimulan Bullet Mat & Introducer (15060155711338)

GUDID

Device Identifier (DI) Information

Brand Name: Stimulan Bullet Mat & Introducer
Version or Model: 660-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 660-001
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 15060155711338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use
Previous DI: 50601557113318

Device Description: The STIMULAN® Bullet Mat and Introducer is a surgical instrument whcih includes a mat for preparation of the STIMULAN® bullets, a 7mm introducer, a 9mm introducer and an obturator for hard to reach defects. To be used with 20cc Stimulan Rapid Cure

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":	Yes
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?
47997	Bone grafting cannula	A rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 4 and 45 Degrees Celsius
Storage Environment Temperature: between 39 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aec1a1f6-09f7-4f9a-8ead-9f1d0e0e0bff
Public Version Date: January 15, 2020
Public Version Number: 1
DI Record Publish Date: January 07, 2020