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Distraction Compression Case

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref MRS-103

by Bradshaw Medical Inc.

Identity

Trade Name
DISTRACTION COMPRESSION CASE FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Case - MRS EUDAMED
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 FDA UDI
Model / Reference
MRS-103 EUDAMEDFDA UDI
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 FDA UDI

Identifiers

Primary DI / UDI-DI
00810019931475 EUDAMEDFDA UDI
Basic UDI-DI
081001993MRS103YL EUDAMED
Direct Marketing DI
00810019931475 EUDAMED
FDA Product Code
LXH FDA UDI
EMDN Code
L1206 LAPAROSCOPIC AND THORACOSCOPIC SURGERY SPREADERS AND RETRACTORS, REUSABLE EUDAMED
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
888.4540 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Distraction Compression Case by Bradshaw Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bradshaw Medical Inc.

Sources (2)

  • FDA UDI f5ec2537-9b93-45a0-9753-2723a0fa2a96 33 fields · synced Jun 18, 2026
  • EUDAMED 8d733787-2d91-42db-a9df-9e979453779d 61 fields · synced Jun 18, 2026