FDA.reportPublic FDA data

SeeStar

Primary DI
07350031353204
Brand
SeeStar
Company
Apriomed AB
Model
13320
Catalog number
13320
Device description
A passive guide for guided invasive access
Published
2020-12-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDFGuide, Needle, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350031353201PackageGS15Not in Commercial Distribution
27350031353208PackageGS112Not in Commercial Distribution
07350031353204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735003135320117350031353201
2735003135320827350031353208
07350031353204073500313532047350031353204

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge20Gauge

Contacts#

Phone, Email table
PhoneEmail
+46184301440info@apriomed.com

Regulatory Flags#

DUNS number
631734758
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350031350623Bonopty Penetration Set10-106210-10622020-12-02
07350031350630Bonopty Biopsy Set10-106310-10632020-12-01
07350031350722Bonopty Penetration Set10-107210-10722020-12-04
07350031350739Bonopty Biopsy Set10-107310-10732020-12-04
07350031350746Bonopty Extended Drill10-107410-10742020-12-04
07350031350821Bonopty Penetration Set10-108210-10822020-12-04
07350031350838Bonopty Biopsy Set10-108310-10832020-12-04
07350031351194Gangi-SoftGuard Coaxial NeedleSG12-121SG12-1212019-01-21
07350031351217Gangi-SoftGuard Coaxial NeedleSG13-071SG13-0712019-01-21
07350031351224Gangi-SoftGuard Coaxial NeedleSG13-121SG13-1212019-01-21
07350031351231Gangi-SoftGuard Coaxial NeedleSG13-171SG13-1712019-01-21
07350031351248Gangi-SoftGuard Coaxial NeedleSG15-071SG15-0712019-01-21
07350031351255Gangi-SoftGuard Coaxial NeedleSG15-121SG15-1212019-01-21
07350031351262Gangi-SoftGuard Coaxial NeedleSG15-171SG15-1712019-01-21
07350031351279Gangi-SoftGuard Coaxial NeedleSG17-071SG17-0712019-01-21
07350031351286Gangi-SoftGuard Coaxial NeedleSG17-121SG17-1212019-01-21
07350031351293Gangi-SoftGuard Coaxial NeedleSG17-171SG17-1712019-01-21
07350031351330Gangi-HydroGuard Coaxial NeedleHG15-121HG15-1212019-01-21
07350031351347Gangi-HydroGuard Coaxial NeedleHG15-171HG15-1712019-01-21
07350031351354Gangi-HydroGuard Coaxial NeedleHG17-121HG17-1212019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344044795MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
10197344044801MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
07630037864523APTUSMedartis AGGDF2025-04-08
07630037864547APTUSMedartis AGGDF2025-04-08
07630037864561APTUSMedartis AGGDF2025-04-08
07630037864585APTUSMedartis AGGDF2025-04-08
10197106342312CARDINAL HEALTHCardinal Health 200, LLCGDF2024-04-01
07630037864165APTUSMedartis AGGDF2024-03-22
ESAM14755481STOMA®Storz am Mark GmbHGDF2023-11-20
ESAM14760481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14761481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14750481STOMA®Storz am Mark GmbHGDF2022-11-07
ESAM14751481STOMA®Storz am Mark GmbHGDF2022-11-07
08033860028596BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860028602BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
08033860030353BIOPSYBELLBIOPSYBELL SRLGDF2022-09-16
10840199534132Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534149Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534156Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534163Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534170Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534187Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534194Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534200Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534217Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534224Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534231Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534248Needle HolderKOROS U.S.A., INC.GDF2022-08-01
10840199534255Needle HolderKOROS U.S.A., INC.GDF2022-08-01