FDA.reportPublic FDA data

SKEETER

Primary DI
00763000299293
Brand
SKEETER
Company
MEDTRONIC XOMED, INC.
Model
3155615
Device description
TRAY 3155615 OTO-TOOL STERILIZATION
Published
2020-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HBCMOTOR, DRILL, ELECTRIC
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
HRXArthroscope
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBCMotor, Drill, ElectricNeurology2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HRXArthroscopeOrthopedic2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081475000ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]Medtronic Xomed, Inc.2008-10-17HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000299293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000299293007630002992937630002992930763000299293

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000032746Neuray®80040052019-03-17
00763000032784Neuray®80040002019-03-17
00763000032791Neuray®80040012019-03-17
00763000032807Neuray®80040022019-03-17
00763000032814Neuray®80040032019-03-17
00763000032821Neuray®80040042019-03-17
00763000032838Neuray®80040062019-03-17
00763000032845Neuray®80040072019-03-23
00763000032869Neuray®80040092019-03-17
00763000843908NIM VitalNIM4CM012026-08-22
00763000843915NIM VitalNIM4CPB12026-08-22
00199150037407NIM™8225825X2026-03-29
00643169644656Otomag™ Attract™ Magnetic SpacerS0266-002016-04-15
00643169644663Otomag™ Attract™ Magnetic SpacerS0266-012016-04-15
00643169644670Otomag™ Attract™ Magnetic SpacerS0266-022016-04-15
00643169644687Otomag™ Attract™ Magnetic SpacerS0266-032016-04-15
00643169644694Otomag™ Attract™ Magnetic SpacerS0266-042016-04-15
00643169644700Otomag™ Attract™ Magnetic SpacerS0266-052016-04-15
00643169644717Otomag™ Attract™ Magnetic SpacerS0266-062016-04-15
00643169644731Otomag™ Attract™ Magnetic SpacerS0266-082016-04-15

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04250337121015Combo Optic AdapterJoimax GmbHHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLHRX2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLHRX2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
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00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mmG21 SRLHRX2026-09-30
08058964728708Winch Kyphoplasty Balloon Catheter 15G 15 mmG21 SRLHRX2026-09-30
10888857596719Xia® 3VB Spine LLCHWE2026-05-12
10888857596726Xia® 3VB Spine LLCHWE2026-05-12
10888857596733Xia® 3VB Spine LLCHWE2026-05-12
J021305020241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHERL2025-07-08
J021305020241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHHWE2025-07-08
08055727374479MIS 3.3 REAMER HANDLEHPF SRLHWE2022-09-08
08055727374486MIS 3.3 REAMER HANDLEHPF SRLHWE2022-09-08
08055727374493MIS 3.3 REAMER HANDLEHPF SRLHWE2022-09-08
08055727374509MIS 3.3 REAMER HANDLEHPF SRLHWE2022-09-08
08055727374516MIS 3.3 REAMER HANDLEHPF SRLHWE2022-09-08
08055727374523MIS 3.3 REAMER HANDLEHPF SRLHWE2022-09-08
08055727374530MIS 3.3 REAMER HANDLEHPF SRLHWE2022-09-08
08055727374547MIS 3.3 REAMER HANDLEHPF SRLHWE2022-09-08
08055727374554MIS 3.3 REAMER HANDLEHPF SRLHWE2022-09-08
08057968711525ADAPTER HC/HPFHPF SRLHWE2022-09-08
08057968716742MIS 4.0 REAMER HANDLE CUP IMPACTORHPF SRLHWE2022-09-08
08057968719033ADAPTER CONN. HC/HPFHPF SRLHWE2022-09-08
00850033250428Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.HRX2022-09-07