FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
10885403067877
Brand
Snowden-Pencer
Company
CAREFUSION 2200, INC
Model
89-8462
Catalog number
89-8462
Device description
Snowden-Pencer MIS SNOWDEN-PENCER HEADLIGHT SYSTEM, ADJUSTABLE SWEATBAND WITH 3.5MM X 9FT BIFURCATED FIBER OPTIC CABLE
Published
2017-06-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBALIGHT, SURGICAL HEADLIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893458000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893458000FIBEROPTIC HEADLIGHT SYSTEMCuda Products Co.1989-06-22EBA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403067877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540306787710885403067877

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)323-9088Customer_Support@BD.com

Regulatory Flags#

DUNS number
832696038
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18
10885403228131Safe-TTPT1005SDFTPT1005SDF2018-07-18
10885403231780JamshidiBAK4511DFBAK4511DF2016-09-23
10885403231896Safe-T-CentesisPIG1260TCDFPIG1260TCDF2018-07-18
10885403231902NATPT1000CDFTPT1000CDF2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095541455zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548157zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548317zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548454zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548515zumaxZumax Medical Co., LTDEBA2026-06-03
06945095546931zumaxZumax Medical Co., LTDEBA2026-06-01
06945095546993zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547037zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547204zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547433zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547440zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547778zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547938zumaxZumax Medical Co., LTDEBA2026-06-01
06945095544258zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544449zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544623zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544883zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545019zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545033zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545040zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545057zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545217zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545231zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545521zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545538zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545569zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545729zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545903zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545934zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546054zumaxZumax Medical Co., LTDEBA2026-05-20