FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
10885403285370
Brand
Snowden-Pencer
Company
STERIS CORPORATION
Model
88-1006K
Catalog number
881006K
Device description
Fiber Optic Light Panel 4 inches 10.2CM
Published
2021-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDGRETRACTOR, FIBEROPTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403285377PackageGS16In Commercial Distribution
10885403285370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540328537720885403285377
1088540328537010885403285370

GMDN Terms#

Term, Definition table
TermDefinition
Open surgical site internal lightAn electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403022470V. MuellerRH600RH6002018-09-14
10885403092084V. MuellerOP0907-601OP09076012018-09-05
10885403092091V. MuellerOP0907-602OP09076022018-09-05
10885403099120V. MuellerOP5000OP50002018-09-07
10885403099137V. MuellerOP5005OP50052018-09-07
10885403099144V. MuellerOP5500OP55002018-09-07
10885403099182V. MuellerOP5505OP55052018-09-07
10885403099199V. MuellerOP5510OP55102018-09-07
10885403099205V. MuellerOP5520OP55202018-09-07
10885403099625V. MuellerOP5666OP56662019-01-02
10885403099717V. MuellerOP5700OP57002019-01-02
10885403099779V. MuellerOP5760OP57602019-01-02
10885403099786V. MuellerOP5761OP57612019-01-02
10885403104909V. MuellerOS4610OS46102018-09-10
10885403113345V. MuellerRH1670RH16702018-09-10
10885403113352V. MuellerRH1680RH16802018-09-10
10885403113369V. MuellerRH1690RH16902018-09-10
10885403113383V. MuellerRH1700RH17002018-09-10
10885403113390V. MuellerRH1701RH17012018-09-10
10885403113406V. MuellerRH1702RH17022018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435240MillenniumAvalign Technologies, Inc.FDG2026-10-19
G141572101010Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210110Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210310Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210630Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210690Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210870Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210920Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G1415543110400Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157204210Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210130Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210200Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572103590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210570Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210670Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572107270Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210830Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
00840329838867N/ABLACK & BLACK SURGICAL, INC.FDG2026-09-29
G425110676LSI0My MedicalMy Medical Store LLCFDG2026-05-04
G425110686LSI0My MedicalMy Medical Store LLCFDG2026-05-04
00812432023140Medtronic Surgical Illuminator - TubeLumitex, Inc.FDG2026-04-17
00812432023157Medtronic Surgical Illuminator - BladeLumitex, Inc.FDG2026-04-17
00812432023218Lumitex Surgical Tube IlluminatorLumitex, Inc.FDG2026-03-23
G4255721131S0My MedicalMy Medical Store LLCFDG2026-02-27
00812432023133Light Cable, Vaginal RetractorLumitex, Inc.FDG2026-02-11
00812432021559Lumitex MD 3.75mm ACMI Reusable Light CableLumitex, Inc.FDG2026-01-29
00812432023164Medtronic 4mm Universal Reusable Light CableLumitex, Inc.FDG2026-01-07
00812432023171Medtronic 4mm ACMI Cable AdapterLumitex, Inc.FDG2026-01-07
00812432023188Medtronic 4mm WOLF Cable AdapterLumitex, Inc.FDG2026-01-07