FDA.reportPublic FDA data

UNBRANDED

Primary DI
10848340001700
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
5005
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
10848340001700PackageGS125In Commercial Distribution
00848340001703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000170010848340001700
00848340001703008483400017038483400017030848340001703

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
10848340010719C-FlexA-707022026-03-12
10848340010481Mitaka DrapeMU51512024-04-17
10848340011464Mitaka Spy EliteMU1202024-04-17
10848340015530Rolled Probe Cover29-PCS28212024-04-16
10848340016834Rolled Probe Cover29-PCS3520LF2024-04-16
10848340016858Rolled Probe Cover29-PCS0330LF2024-04-16
10848340015547Rolled Probe Cover29-PCS35202024-04-15
10848340012089Sterile Elastic BandsBRB6-5X22024-04-14
10848340015486C-Arm Pack10-21762024-04-14
10848340010160Celfina Cover Motor Module10053442024-04-10
1084834001030612" II Tube Drape (36X36)52584972024-04-10
10848340010320Miniview 6800 C-Arm Drape52616332024-04-10
10848340010276Wide Footswitch Cover52534302024-04-09
108483400102839600/9800/9900 Super C 12"52543822024-04-09
108483400102909600/9800/9900 C-Arm Consu.52559362024-04-09
10848340010238Universal 1/2 Drape52333452024-04-08
10848340010245Gray Footswitch Cover52382592024-04-08
10848340017008Leap Med28-TPUA1702024-04-03
10848340017275Leap Med28-TPUA1722024-04-03
10848340016988Leap Med28-TPU1662024-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867500914Arthrex®ARTHREX, INC.DRC2026-03-13
04262494463594N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463631N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463785N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463792N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463808N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463815N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463822N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463839N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463846N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494461064N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461224N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461019N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461026N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461033N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461040N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461057N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461071N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461088N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461095N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461101N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461118N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461125N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461132N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461149N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461156N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461163N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461170N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461187N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461194N/ADoppkon GmbH & Co. KGDRC2025-08-04