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Goblin LS Pedicle Screw System

FDA UDI

Class II (US FDA UDI)

by Medynus, Inc.

Identity

Trade Name
Goblin LS Pedicle Screw System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
MIS Full-closed 6.5 * 40 FDA UDI
Model / Reference
FFM-65040 FDA UDI
Description
MIS Full-closed 6.5 * 40 FDA UDI

Identifiers

Catalog Number
FFM-65040 FDA UDI
Primary DI / UDI-DI
00810088654527 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Lot / Batch Number

No

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: Bone-screw internal spinal fixation system, non-sterile

Goblin LS Pedicle Screw System by Medynus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medynus, Inc.

Sources (1)

  • FDA UDI e3a2d534-4811-4e37-8d52-0631a6d404ba 34 fields · synced May 30, 2026