FDA.reportPublic FDA data

ProTector

Primary DI
H816MPNS5002
Brand
ProTector
Company
MicroCare, LLC
Model
PNS500
Catalog number
PNS500-1
Device description
Needle Sheath Prop
Published
2022-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052725000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052725000PROTECTOR NEEDLE SHEATH PROPCertol International, LLC2005-12-28FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H816MPNS5002PackageHIBCC6In Commercial Distribution
H816PNS5001PreviousHIBCC0
H816MPNS5001PrimaryHIBCC0
H816MPNS5000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, single-useA device intended to be used in the operating room (OR) by staff to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118518186
Device count
500
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H816MPM10161ProView PlusPM1016PM1016-12022-10-26
H816MPM13181ProView PlusPM1318PM1318-12022-10-26
H816MPM24401ProView PlusPM2440PM2440-12022-10-26
H816MPM27901ProView PlusPM2790PM2790-12022-10-26
H816MPM35541ProView PlusPM3554PM3554-12022-10-26
H816MPM35901ProView PlusPM3590PM3590-12022-10-26
H816MPM54101ProView PlusPM5410PM5410-12022-10-26
H816GEL121Spec Clean Pre Treatment GelGEL12GEL122025-10-23
H816OP1281OptizymeOP128OP1282025-10-23
H816PSC050Spec Clean Ready to Use DisinfectantPSC050PSC0502025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantPSC128PSC1282025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantPSC240PSC2402025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantPSC6032PSC60322025-10-23
H816EZ128Spec Clean Single Enzymatic DetergentEZ128EZ1282025-10-22
H816EZTAB641Spec Clean Enzymatic TabletsEZTAB64EZTAB642025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalinePCNF128PCNF1282025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantPLC128PLC1282025-10-22
H816PLR32Spec Clean Instrument LubricantPLR32PLR322025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentPREZ128PREZ1282025-10-22
H816PREZ275Spec Clean Dual Enzymatic DetergentPREZ275PREZ2752025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27