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Pedicle Awl

FDA UDI

Class II (US FDA UDI)

by Premia Spine Ltd

Identity

Trade Name
Pedicle Awl FDA UDI
Generic Name
Bone awl, reusable FDA UDI
Model / Reference
83159 FDA UDI

Identifiers

Primary DI / UDI-DI
07290115934137 FDA UDI
PMA Number
P220002 FDA UDI
510(k) Number
K150380 FDA UDI
K170061 FDA UDI
K231844 FDA UDI
FDA Product Code
NKB FDA UDI
MNH FDA UDI
MNI FDA UDI
QWK FDA UDI
GMDN Term
Bone awl, reusable 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

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: Bone awl, reusable

Pedicle Awl by Premia Spine Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone awl, reusable.

Cleared under the same submission

K150380 also covers:

K170061 also covers:

K231844 also covers:

P220002 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Premia Spine Ltd

Sources (1)

  • FDA UDI 90b243af-8395-4886-b486-5f5a74a0858b 33 fields · synced May 30, 2026