AccessGUDID - DEVICE: BandLoc DUO (00841132150627)

GUDID

Device Identifier (DI) Information

Brand Name: BandLoc DUO
Version or Model: 10-1102-1555
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-1102-1555
Company Name: ORTHOPEDIATRICS CORP.

Primary DI Number: 00841132150627
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796416191 *Terms of Use

Device Description: BandLoc DUO 5.5/6.0 Sterile Implant

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
37272	Trans-facet-screw internal spinal fixation system, sterile	A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OWI	Bone Fixation Cerclage, Sublaminar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161267	000
K200097	000

Device Exempt from Premarket Submission: No 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: 94900513-3db2-42a8-8134-307ce9f1339a
Public Version Date: September 03, 2020
Public Version Number: 2
DI Record Publish Date: February 10, 2020