FDA.reportPublic FDA data

Laser-Shield®

Primary DI
00681490156042
Brand
Laser-Shield®
Company
MEDTRONIC XOMED, INC.
Model
7060300
Device description
ENDOTRACH TUBE 7060300 LASER SHLD 6MM
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
00681490156042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490156042006814901560426814901560420681490156042

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 Gauge27French
Lumen/Inner Diameter6Millimeter
Outer Diameter9Millimeter

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

Other Devices From This Company#

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00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
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00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
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00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
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00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15
00643169644748Otomag™ Attract™ Magnetic SpacerS0266-092016-04-15
00643169644755Otomag™ Attract™ Magnetic SpacerS0266-102016-04-15
00643169644762Otomag™ Attract™ Magnetic SpacerS0266-112016-04-15
00643169644779Otomag™ Attract™ Magnetic SpacerS0266-152016-04-15
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00643169644793Otomag™ Attract™ Magnetic SpacerS0542-002016-04-15
00643169644809Otomag™ Attract™ Magnetic SpacerS0542-012016-04-15
00643169644816Otomag™ Attract™ Magnetic SpacerS0542-022016-04-15
00643169644823Otomag™ Attract™ Magnetic SpacerS0542-032016-04-15

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