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nexis®

FDA UDI

Class I (US FDA UDI)

by Novastep

Identity

Trade Name
nexis® FDA UDI
Generic Name
Cannulated surgical drill bit, single-use FDA UDI
Device Name
Ø3,7 canulated drill bit single-use FDA UDI
Model / Reference
XDB01007D FDA UDI
Description
Ø3,7 canulated drill bit single-use FDA UDI

Identifiers

Catalog Number
XDB01007D FDA UDI
Primary DI / UDI-DI
03700879503035 FDA UDI
FDA Product Code
HWE FDA UDI
GMDN Term
Cannulated surgical drill bit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cannulated surgical drill bit, single-use

nexis® by Novastep — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cannulated surgical drill bit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novastep

Sources (1)

  • FDA UDI 3ff68b4f-1b8d-4637-90bf-420d915ace6d 35 fields · synced May 30, 2026