AccessGUDID - DEVICE: icotec Lumbar Cage, Nerve Root Retractor, 6 mm (07640164841816)

GUDID

Device Identifier (DI) Information

Brand Name: icotec Lumbar Cage, Nerve Root Retractor, 6 mm
Version or Model: 38-034-06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 38-034-06
Company Name: icotec AG

Primary DI Number: 07640164841816
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480789465 *Terms of Use

Device Description: icotec Lumbar Cage, Nerve Root Retractor, 6 mm

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?
46768	Nerve/vessel retractor	A hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. It is a shaft-like metallic instrument with a blunt bulbous or rounded hook-like retraction tip at the distal end, and a handle at the proximal end. It is available in a variety of designs such as, curved, right-angled, or 45 degree angled. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 432027ad-383f-49c0-8f8e-14b137a270ec
Public Version Date: August 06, 2025
Public Version Number: 4
DI Record Publish Date: July 16, 2018