FDA.reportPublic FDA data

NA

Primary DI
10886982128287
Brand
NA
Company
Synthes GmbH
Model
05.001.017
Catalog number
05001017
Device description
FOOT SWITCH-2 PEDALS FOR ELECTRIC PEN DRIVE
Published
2016-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043310000SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)2005-01-05HWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819167759Direct MarkingGS10
10886982128287PrimaryGS10
H679050010170SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819167759076118191677597611819167759
1088698212828710886982128287

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14
10886982077899NA03.311.013033110132015-09-14
10886982078131NA03.311.058033110582015-09-14
10886982078148NA03.311.059033110592015-09-14
10886982078155NA03.311.060033110602015-09-14
10886982078186NA03.311.062033110622015-09-14
10886982078193NA03.311.070033110702015-09-14
10886982078209NA03.311.071033110712015-09-14
10886982078247NA03.311.090033110902015-09-14
10886982078254NA03.311.091033110912015-09-14
10886982078261NA03.311.092033110922015-09-14
10886982078438NA03.311.201033112012015-09-14
10886982078445NA03.311.202033112022015-09-14
10886982078452NA03.311.203033112032015-09-14
10886982078469NA03.311.204033112042015-09-14
10886982078476NA03.311.205033112052015-09-14
10886982078520NA03.311.220033112202015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-06-28
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366217P300-2A100NAKANISHI INC.HWE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HWE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
10886982237217NASYNTHES (U.S.A.) LPHWE2019-02-21
00821925011441DIEGOGyrus ACMI, LLCERL2017-05-11
10886982237613NASynthes GmbHHWE2017-02-20
10886982129512NASynthes GmbHHWE2016-12-31
10886982129598NASynthes GmbHHWE2016-12-31
10886982237729NASynthes GmbHHWE2016-12-31
10886982237989NASynthes GmbHHWE2016-12-31
10886982238795NASynthes GmbHHWE2016-12-31
10886982240323NASynthes GmbHHWE2016-12-31
10886982240347NASynthes GmbHHWE2016-12-31
10886982240361NASynthes GmbHHWE2016-12-31
10886982240385NASynthes GmbHHWE2016-12-31
00821925011410DIEGOGyrus ACMI, LLCERL2016-10-12
00821925028746DiegoGyrus ACMI, LLCERL2016-10-06
10886982064721NASynthes GmbHHWE2016-06-30
10886982064721NASynthes GmbHERL2016-06-30