FDA.reportPublic FDA data

NA

Primary DI
10886982239358
Brand
NA
Company
Synthes GmbH
Model
519.53
Catalog number
51953
Device description
DOUBLE AIR HOSE SYNTHES STEM 5 METERS
Published
2016-12-31
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
HSZINSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982239358PrimaryGS10
H679519530SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698223935810886982239358

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
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2026-03-09
10845854028636POWERPROConmed CorporationHSZ2023-09-01
10845854036198POWERPROConmed CorporationHSZ2023-09-01
10845854036204POWERPROConmed CorporationHSZ2023-09-01
30845854083950CONMEDConmed CorporationHSZ2022-06-06
10845854028384POWERPROConmed CorporationHSZ2021-04-19
10886982186041NASynthes GmbHHSZ2019-12-27
10886982186126NASynthes GmbHHSZ2019-12-27
10886982186317NASynthes GmbHHSZ2019-12-27
10886982186355NASynthes GmbHHSZ2019-12-27
10886982186430NASynthes GmbHHSZ2019-12-27
10886982186454NASynthes GmbHHSZ2019-12-27
10886982186478NASynthes GmbHHSZ2019-12-27
10886982186492NASynthes GmbHHSZ2019-12-27
10886982186515NASynthes GmbHHSZ2019-12-27
10886982186553NASynthes GmbHHSZ2019-12-27
10886982186645NASynthes GmbHHSZ2019-12-27
10886982186706NASynthes GmbHHSZ2019-12-27
10886982186775NASynthes GmbHHSZ2019-12-27
10886982186850NASynthes GmbHHSZ2019-12-27
10886982186874NASynthes GmbHHSZ2019-12-27
10886982185914NASynthes GmbHHSZ2019-12-26
10886982185976NASynthes GmbHHSZ2019-12-26
10886982186034NASynthes GmbHHSZ2019-12-26
10886982186119NASynthes GmbHHSZ2019-12-26
10886982186201NASynthes GmbHHSZ2019-12-26
10886982186218NASynthes GmbHHSZ2019-12-26
10886982186249NASynthes GmbHHSZ2019-12-26
10886982186270NASynthes GmbHHSZ2019-12-26
10886982186294NASynthes GmbHHSZ2019-12-26