FDA.reportPublic FDA data

PremierPro

Primary DI
10818566013429
Brand
PremierPro
Company
SVS LLC
Model
7511
Catalog number
7511
Device description
Safety Lancet Heel Incision Micro-Preemie, Green
Published
2020-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKLancet, Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818566013429PackageGS150In Commercial Distribution
20818566013426PackageGS14In Commercial Distribution
00818566013422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081856601342910818566013429
2081856601342620818566013426
00818566013422008185660134228185660134220818566013422

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0.65Millimeter
Length1.4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699info@s2s-global.com

Regulatory Flags#

DUNS number
831375089
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00811220035495PremierPro882088202024-10-28
00811220035518PremierPro882188212024-10-28
10811220035430PremierProD5061D50612024-03-08
10811220035447PremierProD5062D50622024-03-08
10811220035454PremierProD5063D50632024-03-08
10811220035461PremierProD5064D50642024-03-08
10811220035478PremierProD5065D50652024-03-08
00811220035143PremierProFL1003DFL1003D2024-02-14
00811220035174PremierProFL1005DFL1005D2024-02-14
00811220035099PremierProFL1010DFL1010D2024-02-14
00811220035112PremierProFL1010SFFL1010SF2024-02-14
00811220034412PremierPro™31T1417531T141752022-12-19
00811220034443PremierPro™31T1617731T161772022-12-19
00811220034474PremierPro™31T1811631T181162022-12-19
00811220034504PremierPro™31T1818831T181882022-12-19
00811220034535PremierPro™31T2011631T201162022-12-19
00811220034566PremierPro™31T2010031T201002022-12-19
00811220034597PremierPro™31T2018831T201882022-12-19
00811220034627PremierPro™31T2210031T221002022-12-19
00811220034658PremierPro™31T2407531T240752022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
26931918108718AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
36945630141981STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
06945630141997STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
30885632507070MedichoiceOWENS & MINOR DISTRIBUTION, INC.FMK2026-02-17
00843484108356Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
00843484108370Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
10848530107557DiabeticsSUNSET HEALTHCARE SOLUTIONS, INC.FMK2025-12-19
04719893237139TD-5052 AKTIVSAFE LANCET (Sterile) (21G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
04719893237153TD-5052 AKTIVSAFE LANCET (Sterile) (26G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
04719893237177TD-5052 AKTIVSAFE LANCET (Sterile) (30G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
01850011833123VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833192VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833215VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833222VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833284VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833291VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833307VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833314VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833338VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833352VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833369VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833376VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833383VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833390VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833406VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833413VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833451VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833468VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833512VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833819VerifinePromisemed Medical Devices Inc.FMK2025-11-20