FDA.reportPublic FDA data

Laser-Shield®

Primary DI
00681490156066
Brand
Laser-Shield®
Company
MEDTRONIC XOMED, INC.
Model
7060400
Device description
ENDOTRACH TUBE 7060400 LASER SHLD 7MM
Published
2016-05-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered laser surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901016000LASER-SHIELD II(TM)Xomed, Inc.1990-08-29GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00681490156066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490156066006814901560666814901560660681490156066

GMDN Terms#

Term, Definition table
TermDefinition
Laser-resistant endotracheal tubeA hollow cylinder that is inserted into the trachea used to secure airway patency and/or for anaesthesia administration, and which is not damaged or easily set on fire if inadvertently irradiated by a laser beam during surgery around the head, throat, or neck. This device would typically be employed when laser surgery is being applied to the patient's head/neck area. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge31French
Lumen/Inner Diameter7Millimeter
Outer Diameter10.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Lot or batch
true

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00199150064076ApexCut187BL4000L2026-04-25
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00199150064106ApexCut187BL40602026-04-25
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00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
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00763000945763ApexCut187BL35602026-04-25
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00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
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08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
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