FDA.reportPublic FDA data

UNBRANDED

Primary DI
10848340009263
Brand
UNBRANDED
Company
ADVANCE MEDICAL DESIGNS, INC.
Model
CS02NS
Device description
Control Syringe
Published
2016-09-19
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
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848340009263PackageGS1100In Commercial Distribution
00848340009266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084834000926310848340009263
00848340009266008483400092668483400092660848340009266

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. 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
00810126506757Comfortox3D DENTAL DESIGNS AND DEVELOPMENT, LLCFMF2026-03-24
00810126506764Comfortox3D DENTAL DESIGNS AND DEVELOPMENT, LLCFMF2026-03-24
18699207302025Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207305033Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207310037Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207311003Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207320029Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207350026Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
04046955850839Omnifix®B. BRAUN MEDICAL INC.FMF2026-03-08
18800109007035DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007073DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007127DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
00849296013345WelmedWELMED INC.FMF2026-02-15
00849296013352WelmedWELMED INC.FMF2026-02-15
00849296013369WelmedWELMED INC.FMF2026-02-15
00849296013376WelmedWELMED INC.FMF2026-02-15
00849296013383WelmedWELMED INC.FMF2026-02-15
00849296013390WelmedWELMED INC.FMF2026-02-15
00849296013406WelmedWELMED INC.FMF2026-02-15
00849296013413WelmedWELMED INC.FMF2026-02-15
00849296013420WelmedWELMED INC.FMF2026-02-15
00849296013437WelmedWELMED INC.FMF2026-02-15
00849296013444WelmedWELMED INC.FMF2026-02-15
00849296013451WelmedWELMED INC.FMF2026-02-15
00849296013468WelmedWELMED INC.FMF2026-02-15
00849296013475WelmedWELMED INC.FMF2026-02-15
00849296013482WelmedWELMED INC.FMF2026-02-15
00849296013499WelmedWELMED INC.FMF2026-02-15
00849296013505WelmedWELMED INC.FMF2026-02-15
20850083784007Comfort EZS.D.I. USA, INC.FMF2026-02-13