AccessGUDID - DEVICE: EXPEDIUM SFX (10705034168111)

GUDID

Device Identifier (DI) Information

Brand Name: EXPEDIUM SFX
Version or Model: 189401404
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 189401404
Company Name: DEPUY SPINE, LLC

Primary DI Number: 10705034168111
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107105876 *Terms of Use

Device Description: EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A4 5.5 x 37-41mm

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?
65114	Bone-screw internal spinal fixation system connector	An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease
OSH	Pedicle screw spinal system, adolescent idiopathic scoliosis
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNH	Orthosis, spondylolisthesis spinal fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062196	000
K111136	000
K142460	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
No Device Sizes

Device Record Status

Public Device Record Key: 8f2d091b-4347-46dd-9721-9ffbd25e0305
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)255-2500
Email: xx@xx.xx

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