FDA.reportPublic FDA data

Nexcare™

Primary DI
30051131197917
Brand
Nexcare™
Company
3M COMPANY
Model
IP310
Catalog number
IP310
Device description
IP-310 Nexcare(TM) Earloop Mask , 3 ct
Published
2016-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30051131197917PackageGS16In Commercial Distribution
50051131197911PackageGS14In Commercial Distribution
00051131197916PrimaryGS10
00051141988252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3005113119791730051131197917
5005113119791150051131197911
00051131197916000511311979160511311979160051131197916
00051141988252000511419882520511419882520051141988252

GMDN Terms#

Term, Definition table
TermDefinition
Electrohydraulic lithotripsy systemAn assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)537-21913Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
830016148
Device count
20
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
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15
007073877753083M™ Bair Hugger™55077550772026-05-15
007073877753153M™ Bair Hugger™55577555772026-05-15
007073878188833M™ Bair Hugger™54501545012026-05-15
007073878188903M™ Bair Hugger™55001550012026-05-15
007073878189063M™ Bair Hugger™55502555022026-05-15
007073878189133M™ Bair Hugger™58502585022026-05-15
007073878189203M™ Bair Hugger™63501635012026-05-15
007073878189373M™ Bair Hugger™57502575022026-05-15
007073878189443M™ Bair Hugger™45035450352026-05-15
007073878189513M™ Bair Hugger™45535455352026-05-15
007073878189683M™ Bair Hugger™55078550782026-05-15
007073878189753M™ Bair Hugger™55578555782026-05-15
106058610760643M™ Filtek™6555A3-S6555A3-S2026-05-08
106058610773823M™ Filtek™4867A14867A12026-05-08
106058610773993M™ Filtek™4867A24867A22026-05-08
106058610774053M™ Filtek™4867A34867A32026-05-08
106058610774123M™ Filtek™4867B14867B12026-05-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
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10304040168650CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168926CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168933CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168940CriterionHENRY SCHEIN, INC.FXX2023-06-26
10087701434423Good NeighborShepard Medical Products, Inc.FXX2023-01-06
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10096295137382LeaderShepard Medical Products, Inc.FXX2023-01-06