FDA.reportPublic FDA data

NA

Primary DI
10886982129055
Brand
NA
Company
Synthes GmbH
Model
05.001.084
Catalog number
05001084
Device description
DOUBLE AIR HOSE FOR AIR PEN DRIVE 5 METERS
Published
2016-06-30
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
HBBMOTOR, DRILL, PNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBBMotor, Drill, PneumaticNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093361000SYNTHES AIR PEN DRIVE (APD) SYSTEMSynthes (Usa)2010-04-14HBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819831537Direct MarkingGS10
10886982129055PrimaryGS10
H679050010840SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819831537076118198315377611819831537
1088698212905510886982129055

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic surgical power tool hoseA single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed surgical-grade air or nitrogen (N2) gas from a gas source, usually the central medical gas supply system, to a surgical drilling system or sawing system handpiece or motor to supply it with power. The device is usually from 2 to 5 meters in length and is commonly designed according to ISO5359. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04251388924105VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959954VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959961VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959978VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388960448VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388961001VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2026-03-09
00763000521622MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-08-10
20763000722313ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722337ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000722326ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000722340ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722399MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
20763000722429MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000722401MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000722418MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000988784Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
00763000988791Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
00763000651169Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-22
00763000521813MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-20
00763000714499MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000714505MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
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00763000930837MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-10-03
00763000714482MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714536MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714550MR8 ToolsMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-04-27
00763000732943MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-01-18