FDA.report

Sample pack Safety-Lanz., D/GB

Primary DI
04038917273305
Brand
Sample pack Safety-Lanz., D/GB
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
00.45.849
Catalog number
00.45.849
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
04038917273299PrimaryGS10
04038917273305Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917273299040389172732994038917273299
04038917273305040389172733054038917273305

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
60
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

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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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