AccessGUDID - DEVICE: Excella® (M711EP45400)

GUDID

Device Identifier (DI) Information

Brand Name: Excella®
Version or Model: EP4540
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EP4540
Company Name: Innovasis, Inc.

Primary DI Number: M711EP45400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 156567492 *Terms of Use

Device Description: Ti 6Al 4V (ELI)

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?
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNH	Orthosis, Spondylolisthesis Spinal Fixation
MNI	Orthosis, Spinal Pedicle Fixation
KWP	Appliance, Fixation, Spinal Interlaminal
NKB	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071921	000

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
Length: 40 Millimeter
Outer Diameter: 4.5 Millimeter

Device Record Status

Public Device Record Key: 5b894405-11e9-4edb-8cfe-4ebf4e99c8fb
Public Version Date: May 22, 2024
Public Version Number: 4
DI Record Publish Date: September 17, 2014

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: Yes
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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 801-261-2236
Email: info@innovasis.com

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