BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

PEDIGUARD CURV

DI: 03662674000044 · Model: PEDIGUARD CURV · SPINEGUARD

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Product Codes

2

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: PEDIGUARD CURV
Primary DI: 03662674000044
Version / Model: PEDIGUARD CURV
Catalog Number: P1-AU450
Company Name: SPINEGUARD
Labeler DUNS: 260589566
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-08-29
Public Version: 5
Public Version Date: 2025-08-29
Public Version Status: Update
Public Device Record Key: 985649ca-493f-444d-b28f-e1612d980f98

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETN	Stimulator, Nerve	Ear, Nose, Throat	874.1820	2
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	874.1820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66274	Bone awl, single-use	A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03662674000044	GS1

Customer Contacts

Phone: +33145184519
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K143159	000

Device Sizes

Type	Value	Unit	Text
Length	55	Millimeter
Outer Diameter	2.5	Millimeter

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -5 – 30 Degrees Celsius
Type: Handling Environment Temperature
Temperature Range: -10 – 50 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: – 90 Percent (%) Relative Humidity
Type: Handling Environment Humidity
Temperature Range: – 90 Percent (%) Relative Humidity