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SpineTIP

FDA UDI

Class II (US FDA UDI)

by Karl Storz GmbH & Co. KG

Identity

Trade Name
SpineTIP FDA UDI
Generic Name
Endoscope sheath, reusable FDA UDI
Device Name
Operation sheath,with oblique,OD 7.8 mm FDA UDI
Model / Reference
28163TSW FDA UDI
Description
Operation sheath,with oblique,OD 7.8 mm FDA UDI

Identifiers

Primary DI / UDI-DI
04048551272817 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Endoscope sheath, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 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

Category: Endoscope sheath, reusable

SpineTIP by Karl Storz GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope sheath, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Karl Storz GmbH & Co. KG

Sources (1)

  • FDA UDI 34eec7ce-30b7-4f21-9360-ccd12cbf4946 33 fields · synced Jun 7, 2026