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Shukla Trephine S9TREPHINE

FDA UDI

Class I (US FDA UDI)

by Shukla Medical

Identity

Trade Name
Shukla Trephine S9TREPHINE FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Device Name
Trephine, 6mm, Single Use, Sterile Packed FDA UDI
Model / Reference
STR001-06-SP FDA UDI
Description
Trephine, 6mm, Single Use, Sterile Packed FDA UDI

Identifiers

Primary DI / UDI-DI
B756STR00106SP0 FDA UDI
FDA Product Code
HWK FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, single-use

Shukla Trephine S9TREPHINE by Shukla Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shukla Medical

Sources (1)

  • FDA UDI c62b525f-f709-42a5-a811-2ce0b4d9dbbb 35 fields · synced Jun 8, 2026