FDA.reportPublic FDA data

Key Surgical Light Handle Cover

Primary DI
10849771030611
Brand
Key Surgical Light Handle Cover
Company
KEY SURGICAL, INC.
Model
LHC-302-080
Catalog number
LHC-302-080
Device description
2 Light Handle Cover; green, disposable; pouch
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTALight, Surgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150532000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150532000Universal Light Handle Cover, Light Handle CoverKey Surgical, Inc.2015-09-22FTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849771030611PackageGS180In Commercial Distribution
00849771030614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084977103061110849771030611
00849771030614008497710306148497710306140849771030614

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags#

DUNS number
604056226
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849771039997Key Surgical Sterile LabelsSL118SL1182022-11-02
10849771043178Sterile LabelsSL212SL2122023-04-18
10849771050718Sterile LabelsSL202SL2022023-04-24
10849771052767Sterile LabelsSL101SL1012024-03-22
10849771052774Sterile LabelsSL103SL1032024-03-22
10849771052781Sterile LabelsSL104SL1042024-03-22
10849771052798Sterile LabelsSL107SL1072024-03-22
10849771052804Sterile LabelsSL110SL1102024-03-22
10849771052842Sterile LabelsSL201SL2012024-03-22
10849771052866Sterile LabelsSL208SL2082024-03-22
10849771052910Sterile LabelsSL213SL2132023-04-18
10849771052927Sterile LabelsSL214SL2142023-04-18
00849771040071NAInstrument StringerIS425142023-01-26
00849771040088NAInstrument StringerIS425162023-01-26
00849771052203NAInstrument StringerIS5350082023-01-26
00849771052210NAInstrument StringerIS555142023-01-26
00849771052166NAInstrument StringersIS125122024-02-12
00849771031307Key Surgical Indicator Dot Locking TagsLS-105LS-1052020-01-29
00849771032588Key Surgical Indicator Dot Locking TagsLS-104LS-1042020-01-29
00849771048596NAPlastic Sterilization TrayPST2100SB2023-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918170732InvenioGRI Medical & Electronic Technology Co., Ltd.FTA2026-04-17
10748426144560Medline-MicrotekMicrotek Medical LLCFTA2026-02-18
00748426142934Skytron®Microtek Medical LLCFTA2026-02-05
00748426145027NAMicrotek Medical LLCFTA2026-02-05
20748426262704Medline-MicrotekMicrotek Medical LLCFTA2026-01-05
80080196761844MEDLINEMEDLINE INDUSTRIES, INC.FTA2025-11-04
10724995245457HexaLuxSTERIS CORPORATIONFTA2025-05-05
20885380184113CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184120CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
20885380184137CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
50885380184787CARDINAL HEALTHCardinal Health 200, LLCFTA2023-12-28
00724995203399NASTERIS CORPORATIONFTA2023-11-17
10197344006915MedlineMEDLINE INDUSTRIES, INC.FTA2023-11-05
50885380183001CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
50885380182998CARDINAL HEALTHCardinal Health 200, LLCFTA2023-08-11
16931918117362AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2023-07-20
16931918159256AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-26
16931918133201AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
16931918196565AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2022-11-22
00748426118526Skytron Lite-LokMicrotek Medical LLCFTA2022-08-08
10193489003093MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489003109MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
10193489005875MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.FTA2021-11-03
00749756725538DeRoyalDEROYAL INDUSTRIES, INC.FTA2021-08-23
G018DLH010Physician's ChoiceSupply Line International Medical, LLCFTA2021-08-05
10850009233018SurgiLight Adapter - AIM-100BihlerMed, L.L.C.FTA2021-06-02
16931918155524AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918167046AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918173153AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-04-22
16931918127309AllesetGRI Medical & Electronic Technology Co., Ltd.FTA2021-03-08