FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
10841336108995
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
2000
Catalog number
2000
Device description
Individual Salvin 2000 Head & Neck Surgery Pack
Published
2025-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKKSUDAN IV

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKKSudan IvHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964142000MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSMedline Industries, Inc.1997-02-25KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841336108995PackageGS18In Commercial Distribution
00841336108998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084133610899510841336108995
00841336108998008413361089988413361089980841336108998

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113344790
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00841336111905Allo-3D-PlusALLO-3D-PLUS-1.0ALLO-3D-PLUS-1.02024-07-11
00841336111912Allo-3D-PlusALLO-3D-PLUS-2.0ALLO-3D-PLUS-2.02024-07-11
00841336138766Salvin Dental SpecialtiesOFIBER-0.5CCOFIBER-0.5CC2025-09-28
00841336138773Salvin Dental SpecialtiesOFIBER-1.0CCOFIBER-1.0CC2025-09-28
00841336138797Salvin Dental SpecialtiesOFIBER-PLUS-0.5CCOFIBER-PLUS-0.5CC2025-09-28
00841336138803Salvin Dental SpecialtiesOFIBER-PLUS-1.0CCOFIBER-PLUS-1.0CC2025-09-28
00841336114395Salvin Dental SpecialtiesDEMIN-CORT-L-5.0DEMIN-CORT-L-5.02024-12-11
00841336125704Salvin Dental SpecialtiesSALVINOSS-0.5SALVINOSS-0.52024-12-11
00841336125711Salvin Dental SpecialtiesSALVINOSS-1.0SALVINOSS-1.02024-12-11
00841336125728Salvin Dental SpecialtiesSALVINOSS-2.5SALVINOSS-2.52024-12-11
00841336125735Salvin Dental SpecialtiesSALVINOSS-COLL-100MGSALVINOSS-COLL-100MG2024-12-11
00841336125759Salvin Dental SpecialtiesSALVINOSS-COLL-250MGSALVINOSS-COLL-250MG2024-12-11
00841336136229Salvin Dental SpecialtiesMIN-CAN-2.00MIN-CAN-2.002024-12-11
00841336138780Salvin Dental SpecialtiesOFIBER-2.5CCOFIBER-2.5CC2024-12-11
00841336111929SALVINOSS-BSALVINOSS-B-0.52024-05-27
00841336111936SALVINOSS-BSALVINOSS-B-1.02024-05-27
00841336111943SALVINOSS-BSALVINOSS-B-2.02024-05-27
00841336111950SALVINOSS-BSALVINOSS-B-4.02024-05-27
00841336111998SALVINOSS-BSALVINOSS-B-SYR-0.252024-05-27
00841336112001SALVINOSS-BSALVINOSS-B-SYR-0.502024-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336101012Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108813Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336108998Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00841336114630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336108810Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
10841336114637Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKKK2025-09-28
00840216101784ASP Medical Asp Global, LLCKKK2022-08-02
10840216101781ASP Medical Asp Global, LLCKKK2022-08-02
10634916809401Side DrapeSTANDARD TEXTILE CO., INC.KKK2021-06-11
10888277563889MedlineMEDLINE INDUSTRIES, INC.KKK2021-02-05
40888277563880MedlineMEDLINE INDUSTRIES, INC.KKK2021-02-05
10080196895410MedlineMEDLINE INDUSTRIES, INC.KKK2021-01-26
10080196747924MedlineMEDLINE INDUSTRIES, INC.KKK2020-12-17
00851354004264Sterile DrapeAVINGER, INC.KKK2019-03-21
20845225012698DIGITAL IVUS STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2017-03-02
10080196308200MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196722938MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
10080196915033MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
40080196308201MedlineMEDLINE INDUSTRIES, INC.KKK2016-10-14
00801902081490ARROWTELEFLEX INCORPORATEDKKK2016-09-16
30801902081491ARROWTELEFLEX INCORPORATEDKKK2016-09-16
20845225012681SpinVision STERILE EQUIPEMENT COVERVOLCANO CORPORATIONKKK2016-09-08
10845225012707R-100 STERILE EQUIPMENT COVERPhilips Image Guided Therapy CorporationKKK2016-09-08
10885380064234CONVERTORSCardinal Health 200, LLCKKK2016-06-28
50885380064232CONVERTORSCardinal Health 200, LLCKKK2016-06-28