AccessGUDID - DEVICE: SCANLAN® MicroSurgical Instruments (00846159027891)

GUDID

Device Identifier (DI) Information

Brand Name: SCANLAN® MicroSurgical Instruments
Version or Model: 1820-07
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1820-07
Company Name: SCANLAN INTERNATIONAL INC

Primary DI Number: 00846159027891
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023055619 *Terms of Use

Device Description: Joseph Double Hook

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:	No
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?
61100	Neurosurgical probe	A non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZX	Instrument, Microsurgical

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba85aa47-9db5-4c0f-b34f-aa1ff84bfbf7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 18, 2016