AccessGUDID - DEVICE: Neoligaments TM (05060267130716)

GUDID

Device Identifier (DI) Information

Brand Name: Neoligaments TM
Version or Model: 202-3008
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: n/a
Company Name: XIROS LTD

Primary DI Number: 05060267130716
Issuing Agency: GS1
Commercial Distribution End Date: April 28, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 228209805 *Terms of Use

Device Description: 20cm Flexible Probe with Eye

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?
35210	Exploratory blunt needle, single-use	A sterile, slender, hand-held manual instrument designed with a dull curved tip intended to prevent damage to sensitive and delicate tissues while it is being used to explore within the body. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAB	Needle, Suturing, Disposable

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c9c5a97-04b0-4506-b259-3e10d43ca322
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 09, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4401132387202
Email: enquiries@neoligaments.com

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