FDA.report

Safety-Needle

Primary DI
04038917250474
Brand
Safety-Needle
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
85.1162.600
Catalog number
85.1162.600
Device description
Safety-Needle 21Gx for metal analysis
Published
2016-09-16
Public version status
Update
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications

CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038917361934PackageGS1500In Commercial Distribution
04038917250474PrimaryGS10
04038917250481Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038917361934040389173619344038917361934
04038917250474040389172504744038917250474
04038917250481040389172504814038917250481

GMDN Terms

TermDefinition
Non-fixed blood collection needleA sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.

Contacts

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

Regulatory Flags

DUNS number
388000270
Device count
50
DM exempt
false
Premarket exempt
false
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
04038917085519S-Monovette®-Needle85.116085.11602016-09-16
04038917086370S-Monovette®-Needle85.137285.13722016-09-16
04038917086387S-Monovette®-Needle85.137385.13732016-09-16
04038917086653S-Monovette®-Needle85.144085.14402016-09-16
04038917086660S-Monovette®-Needle85.144185.14412016-09-16
04038917126021Safety-Needle85.1160.20085.1160.2002016-09-16
04038917126045Safety-Needle85.1162.20085.1162.2002016-09-16
04038917127943Safety-Needle85.1372.20085.1372.2002016-09-16
04038917127950Safety-Needle85.1373.20085.1373.2002016-09-16
04038917129190Safety-Needle85.1440.20085.1440.2002016-09-16
04038917129206Safety-Needle85.1441.20085.1441.2002016-09-16
04038917530590Safety-Needle 23Gx1"85.1442.20085.1442.2002025-05-02
04038917085526S-Monovette®-Needle85.116285.11622016-09-16
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10386120014224RELI®MYCO MEDICAL SUPPLIES INC.JKA2026-02-02
10386120014231RELI®MYCO MEDICAL SUPPLIES INC.JKA2026-02-02
10386120014248RELI®MYCO MEDICAL SUPPLIES INC.JKA2026-02-02
00810184642213GCB Medical SupplyGCB MEDICAL LLCJKA2026-01-28
00810184642220GCB Medical SupplyGCB MEDICAL LLCJKA2026-01-28
00810184642237GCB Medical SupplyGCB MEDICAL LLCJKA2026-01-28
50382903678438BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection TubesBECTON, DICKINSON AND COMPANYJKA2026-01-27
20197344132918MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
20197344132925MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
00850073657041Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
00850073657065Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
10850073657024Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
00850073657027Navi Needle-free Blood Collection DeviceVenocare, Inc.JKA2026-01-20
20850074089067SurgycoSurgyco LLCJKA2025-12-23
20850074089074SurgycoSurgyco LLCJKA2025-12-23
20850074089081SurgycoSurgyco LLCJKA2025-12-23
20850074089098SurgycoSurgyco LLCJKA2025-12-23
20850074089104SurgycoSurgyco LLCJKA2025-12-23
20850074089111SurgycoSurgyco LLCJKA2025-12-23
00850058457031BD MiniDraw Capillary Tube Adapter SSTBabson Diagnostics, Inc.JKA2025-12-09
30351688010180PortexICU MEDICAL, INC.JKA2025-11-24
04038917983259S-Monovette® 1.6ml Serum CATSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983280S-Monovette® 1.6ml Serum CATSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983310S-Monovette® 1.6ml Serum CATSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983372S-Monovette® 1.6ml LHSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
040389179834021,6ml S-Monov. LiI-HEPSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
04038917983433S-Monovette® 1.6ml LHSarstedt Aktiengesellschaft & Co.KGJKA2025-09-25
20612479275649McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
20612479275670McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
20612479275700McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14