FDA.reportPublic FDA data

UNBRANDED

Primary DI
10848340001694
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
5004
Device description
Arterial Needle
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340001694PackageGS125In Commercial Distribution
00848340001697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000169410848340001694
00848340001697008483400016978483400016970848340001697

GMDN Terms#

Term, Definition table
TermDefinition
Intra-arterial needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to puncture an artery. The needle may be heparinized to prevent blood clotting. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
130785884
Device count
1
DM exempt
true
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848340018213Urological Drainage BagKTEK84112026-05-07
00848340018220Urological Drainage BagKYRA84102026-04-15
00848340018206Urological Drainage BagKTEK84102026-04-13
00848340010712C-FlexA-707022026-03-12
10848340010719C-FlexA-707022026-03-12
00848340014857Asonic GelASG-0012023-06-13
00848340002212Transducer Cover05-TC9962024-02-05
00848340002229Custom Cover08-CC1242024-02-06
00848340002236Custom Cover08-CC1342024-02-07
00848340002243Custom Cover08-CC1372024-02-07
00848340002250Custom Cover08-CC1392024-02-08
00848340002267Custom Cover08-CC1402024-02-08
00848340002281Camera Cover08-CC1492024-02-12
00848340002298Cassette Drape08-CC1502024-02-15
00848340002311Snap Kover08-CC1622024-02-15
00848340002328Custom Pack08-CC1632024-02-15
00848340002335Custom Pack08-CC1702024-02-20
00848340002342Positioning Arm Drape08-CU15612024-02-21
00848340002359Doppler Flow Wire CoverDFC1002024-03-13
00848340002366Doppler Flow Wire CoverDFC1012024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731135391Redemption VILEX LLCDRC2026-01-12
10192253057218ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057225ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057232ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057249ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057256ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057263ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057287ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253065237ArgyleCardinal Health 200, LLCDRC2024-08-02
00858769006425SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006449SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006456SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006470SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
10884450412708Merit Advance®Merit Medical Systems, Inc.DRC2024-03-29
00858769006418SafeSept Transseptal GuidewirePPMDMDRC2022-09-26
00858769006364SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006371SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006388SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006395SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006401SafeSept Blunt NeedlePPMDMDRC2021-03-15
M752TSBRF6640Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-10-26
M752TN170313069C0Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-06-16
00849233009059Busse Hospital DiposablesROBERT BUSSE & CO., INC.DRC2020-04-08
00858769006197Transseptal NeedlePPMDMDRC2018-11-28
00858769006203Transseptal NeedlePPMDMDRC2018-11-28
00858769006210Transseptal NeedlePPMDMDRC2018-11-28
00858769006241Transseptal NeedlePPMDMDRC2018-11-28
00858769006258Transseptal NeedlePPMDMDRC2018-11-28
10884450151850Merit Advance®Merit Medical Systems, Inc.DRC2018-06-11
00858769006104SafeSept Transseptal GuidwirePPMDMDRC2018-03-02