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Inner Dilator

FDA UDI

Class II (US FDA UDI)

by Premia Spine Ltd

Identity

Trade Name
Inner Dilator FDA UDI
Generic Name
Hand-held surgical retractor, reusable FDA UDI
Model / Reference
86034 FDA UDI

Identifiers

Primary DI / UDI-DI
07290115934182 FDA UDI
510(k) Number
K150380 FDA UDI
K170061 FDA UDI
K182598 FDA UDI
K231844 FDA UDI
FDA Product Code
NKB FDA UDI
MNI FDA UDI
MNH FDA UDI
GMDN Term
Hand-held surgical retractor, 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: Hand-held surgical retractor, reusable

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

Similar devices

Also classified as Hand-held surgical retractor, reusable.

Cleared under the same submission

K150380 also covers:

K170061 also covers:

K182598 also covers:

K231844 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 b7faf981-8abc-40a2-ae25-e447098f2495 33 fields · synced Jun 6, 2026