TLS 5.0

GUDID B0301000501400

T-Handle, QC, 1/4" Square Adapter

CAMBER SPINE TECHNOLOGIES, LLC

Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting Surgical instrument handle, torque-limiting

Primary Device ID	B0301000501400
NIH Device Record Key	b0d0656a-5b8f-46ce-bbcc-6267d3075993
Commercial Distribution Status	In Commercial Distribution
Brand Name	TLS 5.0
Version Model Number	100-05-0140
Company DUNS	054205979
Company Name	CAMBER SPINE TECHNOLOGIES, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com
Phone	+1(484) 427-7060
Email	quality@cambermedtech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B0301000501400 [Primary]

FDA Product Code

LXH	Orthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

[B0301000501400]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-11-13
Device Publish Date	2023-11-03

On-Brand Devices [TLS 5.0]

B030CX3010150	Interbody Fusion Device 7DEG x30L x 10W x15H
B030CX3010140	Interbody Fusion Device 7DEG x30L x 10W x14H
B030CX3010130	Interbody Fusion Device 7DEG x30L x 10W x13H
B030CX3010120	Interbody Fusion Device 7DEG x30L x 10W x12H
B030CX3010110	Interbody Fusion Device 7DEG x30L x 10W x11H
B030CX3010100	Interbody Fusion Device 7DEG x30L x 10W x10H
B030CX3010090	Interbody Fusion Device 7DEG x30L x 10W x9H
B030CX3010080	Interbody Fusion Device 7DEG x30L x 10W x8H
B030CX3010070	Interbody Fusion Device 7DEG x30L x 10W x7H
B030CX2610150	Interbody Fusion Device 7DEG x 26L x 10W x 15H
B030CX2610140	Interbody Fusion Device 7DEG x 26L x 10W x 14H
B030CX2610130	Interbody Fusion Device 7DEG x 26L x 10W x 13H
B030CX2610120	Interbody Fusion Device 7DEG x 26L x 10W x 12H
B030CX2610110	Interbody Fusion Device 7DEG x 26L x 10W x 11H
B030CX2610100	Interbody Fusion Device 7DEG x 26L x 10W x 10H
B030CX2610090	Interbody Fusion Device 7DEG x 26L x 10W x 9H
B030CX2610080	Interbody Fusion Device 7DEG x 26L x 10W x 8H
B030CX2610070	Interbody Fusion Device 7DEG x 26L x 10W x 7H
B030CX2210150	Interbody Fusion Device 7DEG x 22L x 10W x 15H
B030CX2210140	Interbody Fusion Device 7DEG x 22L x 10W x 14H
B030CX2210130	Interbody Fusion Device 7DEG x 22L x 10W x 13H
B030CX2210120	Interbody Fusion Device 7DEG x 22L x 10W x 12H
B030CX2210110	Interbody Fusion Device 7DEG x 22L x 10W x 11H
B030CX2210100	Interbody Fusion Device 7DEG x 22L x 10W x 10H
B030CX2210090	Interbody Fusion Device 7DEG x 22L x 10W x 9H
B030CX2210080	Interbody Fusion Device 7DEG x 22L x 10W x 8H
B030CX2210070	Interbody Fusion Device 7DEG x 22L x 10W x 7H
B030CK2810150	Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 15H
B030CK2810140	Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 14H
B030CK2810130	Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 13H
B030CK2810120	Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 12H
B030CK2810110	Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 11H
B030CK2810100	Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 10H
B030CK2810090	Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 9H
B030CK2810080	Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 8H
B030CK2810070	Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 7H
B030CK2412150	Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 15H
B030CK2412140	Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 14H
B030CK2412130	Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 13H
B030CK2412120	Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 12H
B030CK2412110	Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 11H
B030CK2412100	Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 10H
B030CK2412090	Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 9H
B030CK2412080	Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 8H
B030CK2412070	Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 7H
B030CK2212150	Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 15H
B030CK2212140	Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 14H
B030CK2212130	Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 13H
B030CK2212120	Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 12H
B030CK2212110	Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 11H

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