FDA.reportPublic FDA data

Safety-Lancet Extra 18G

Primary DI
04038917085045
Brand
Safety-Lancet Extra 18G
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
85.1017
Catalog number
85.1017
Published
2022-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKSingle use only blood lancet with an integral sharps injury prevention feature

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
04038917085045PrimaryGS10
04038917167161Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917085045040389170850454038917085045
04038917167161040389171671614038917167161

GMDN Terms#

Term, Definition table
TermDefinition
Manual blood lancing device, single-useA sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
388000270
Device count
200
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038917927048Sediplus® S 2000 NX90.109290.10922026-07-22
04038917124614TUBE SEGMENT OPENER ASM TB 75/12 PS95.1000.47695.1000.4762026-07-21
04038917124935ESR RACK N/BACK PANEL90.1060.06290.1060.0622026-07-21
04038917390835TUBE SEGMENT OPENER ASM TB 75/ 12 PS CB95.1000.47795.1000.4772026-07-21
04038917581882Salivette®51.1534.10051.1534.1002026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PP62.617.00162.617.0012026-07-21
04066916055837Screw cap, pastel-green65.716.04565.716.0452026-07-21
04066916055998Screw cap, pastel-orange65.716.04665.716.0462026-07-21
04066916056049Screw cap, pastel-violet65.716.04865.716.0482026-07-21
04066916056148Screw cap, pastel-yellow65.716.04265.716.0422026-07-21
04066916056407Screw cap, pastel-blue65.716.04165.716.0412026-07-21
04066916057831SafeSeal tube 0.5ml72.704.05072.704.0502026-07-21
04066916057879SafeSeal tube 0.5ml, brown72.704.05172.704.0512026-07-21
04066916058012SafeSeal tube 0.5ml, red72.704.05272.704.0522026-07-21
04066916058050SafeSeal tube 0.5ml, yellow72.704.05472.704.0542026-07-21
04066916058135SafeSeal tube 0.5ml, green72.704.05572.704.0552026-07-21
04066916058173SafeSeal tube 0.5ml, blue72.704.05672.704.0562026-07-21
04066916058210Micro tube 0.5ml SafeSeal72.704.45072.704.4502026-07-21
04066916058296SafeSeal tube 1.5ml72.706.05072.706.0502026-07-21
04066916058340SafeSeal tube 1.5ml, brown72.706.05172.706.0512026-07-21

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Primary DI, Brand, Company table
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00810178887767Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00816042013638FORAFORA CARE INC.FMK2026-06-23
00199536930407BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930414BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930421BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
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08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22
10840330705643ProCureTwin Med, LLCFMK2026-04-22
10840330705650ProCureTwin Med, LLCFMK2026-04-22
16931918108711AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
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