← Back to catalogue

General Instrument

FDA UDI

Class I (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
General Instrument FDA UDI
Generic Name
Surgical instrument handle, torque-limiting FDA UDI
Device Name
20 inlb Ratcheting Torque Limiting Handle FDA UDI
Model / Reference
CI-10981 FDA UDI
Description
20 inlb Ratcheting Torque Limiting Handle FDA UDI

Identifiers

Primary DI / UDI-DI
00840180508954 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical instrument handle, torque-limiting 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

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

Yes

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: Surgical instrument handle, torque-limiting

General Instrument by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument handle, torque-limiting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI 4821b74a-ba9f-464b-897d-aacdb6e7f580 34 fields · synced Jun 8, 2026