FDA.report

Safety-Lancet Neonatal

Primary DI
04038917167185
Brand
Safety-Lancet Neonatal
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
85.1019
Catalog number
85.1019
Published
2022-11-30
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

Related Records

Contact Domains

Product Codes

CodeName
FMKSingle use only blood lancet with an integral sharps injury prevention feature

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917085069PrimaryGS10
04038917167185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917085069040389170850694038917085069
04038917167185040389171671854038917167185

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags

DUNS number
388000270
Device count
200
DM exempt
true
Premarket exempt
true
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 DIBrandModelCatalogPublished
0403891739991310ml TBE 100x16 PP RED SCW CAP51.9923.83051.9923.8302023-01-18
04038917429948Tube 10ml, 100x16mm, PP62.9924.28062.9924.2802023-01-18
04066916044077Tube with cap, 82x13mm60.550.14160.550.1412025-09-26
04038917167918Haemo-Diff®14.121814.12182025-09-25
04038917983259S-Monovette® 1.6ml Serum CAT04.291104.29112025-09-25
04038917983280S-Monovette® 1.6ml Serum CAT04.2911.00104.2911.0012025-09-25
04038917983310S-Monovette® 1.6ml Serum CAT04.2911.20004.2911.2002025-09-25
04038917983372S-Monovette® 1.6ml LH04.291304.29132025-09-25
040389179834021,6ml S-Monov. LiI-HEP04.2913.00104.2913.0012025-09-25
04038917983433S-Monovette® 1.6ml LH04.2913.20004.2913.2002025-09-25
040669160437422.0ml SC Micro Tube protein LB72.694.63072.694.6302025-09-25
04066916044534SCMTube 0,5 ml72.730.34672.730.3462025-09-25
04038917310949Biosphere® screw cap, white65.716.24265.716.2422025-07-25
04038917326698Biosphere® Screw Cap, green65.716.22565.716.2252025-07-25
04038917328289Biosphere® screw cap, orange65.716.22665.716.2262025-07-25
04038917369909Biosphere® Screw Cap, red65.716.22365.716.2232025-07-25
04038917411769Biosphere® screw cap, yellow65.716.21265.716.2122025-07-25
04038917411790Biosphere® Screw Cap, violet65.716.22865.716.2282025-07-25
04038917411820Biosphere® Screw Cap, blue65.716.22165.716.2212025-07-25
04038917411851Biosphere® Screw Cap, black65.716.22765.716.2272025-07-25

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