AccessGUDID - DEVICE: DISTRACTION COMPRESSION CASE (00810019931475)

GUDID

Device Identifier (DI) Information

Brand Name: DISTRACTION COMPRESSION CASE
Version or Model: MRS-103
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Bradshaw Medical, Inc.

Primary DI Number: 00810019931475
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621830582 *Terms of Use

Device Description: A distraction-compression case is a kit, or a set of instruments designed to perform distraction and compression on a bony structure. The instruments within the case are used to: Distract: To pull apart or lengthen two adjacent bony segments. This is often done to restore anatomical alignment, decompress a nerve, or create a space for a bone graft or implant. Compress: To push together two bony segments. This is typically done to stabilize a fracture, achieve a solid fusion, or close a gap between bones. These kits are essential for orthopedic and spinal surgeons to manipulate bones and achieve proper fixation

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):	No
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?
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

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: 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: f5ec2537-9b93-45a0-9753-2723a0fa2a96
Public Version Date: August 18, 2025
Public Version Number: 1
DI Record Publish Date: August 08, 2025