FDA.reportPublic FDA data

PERCUTANEOUS INTRO NEEDLE F/G

Primary DI
20858690006437
Brand
PERCUTANEOUS INTRO NEEDLE F/G
Company
RANFAC CORP.
Model
PIN-15
Catalog number
PIN-15
Device description
PERCUTANEOUS INTRO NEEDLE F/G PIN-15 75010-01M
Published
2017-05-02
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858690006430PackageGS110In Commercial Distribution
20858690006437PackageGS116In Commercial Distribution
00858690006433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085869000643010858690006430
2085869000643720858690006437
00858690006433008586900064338586900064330858690006433

GMDN Terms#

Term, Definition table
TermDefinition
Non-vascular catheter introduction setA collection of sterile, invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5085884400info@ranfac.com

Regulatory Flags#

DUNS number
121622872
Device count
1
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9797405001M9NDL, RBN-114, STERILE, F/G11 GAUGE x 4"RBN-1142017-05-08
M9797405003M9NDL, RBN-133, STERILE, F/G13 GAUGE x 3"RBN-1332017-05-08
M9797405005M9NDL, RBN-13213 GAUGE x 2"RBN-1322017-05-08
10850075308016HYDRACELL-ORTHO-511 Gauge x 6.1CM 5ccHYDRA-ORTHO-52025-09-25
10850075308030HYDRACELL-ORTHO-1011 Gauge x 6.1CM 10ccHYDRA-ORTHO-102025-09-25
10850075308047HYDRACELL-EXT-511 Gauge x 6.3 CM 5ccHYDRA-EXT-52025-09-25
10850075308061HYDRACELL-EXT-1011 Gauge x 6.3 CM 10ccHYDRA-EXT-102025-09-25
10850075308115Cervos Platelet Separator Triple Pack B2CER-PRP-TRIPLE-B2CER-PRP-TRIPLE-B22025-07-23
00850075308002Ranfac Biopsy Needle, 11GA, 4"11GA X 4"RBN-114SS2025-05-31
10850075308023Cervos Platelet Separator Single 5 PackCER-PRP-SINGLE-5CER-PRP-SINGLE-52025-05-14
10850023741995CER-SUB-1590 CE15 GA X 90 MMCER-SUB-15902024-10-17
10850023741988Cervos Platelet Single BCER-PRP-SINGLE-BCER-PRP-SINGLE-B2024-09-10
10857878007313MAXX-CELL-311GA X 11CMMXC-32024-09-09
10850023741964BANRAN-1111GA X 4CMBANRAN-112024-07-10
10850023741896CER-PRP-JUVA CER-PRP-JUVACER-PRP-JUVA2024-05-15
00850023741929CER-JUVA-BD ASSEMBLYCER-JUVA-BD2024-05-15
00850023741936CER-PRP-JUVA-KITCER-PRP-JUVA-KITCER-PRP-JUVA-KIT2024-05-15
10850023741957MC-RAN-BZL-8C11GA X 9CMMC-RAN-BZL-8C2024-05-06
10850023741940MC-RAN-BZL-8C11GA X 9CMMC-RAN-BZL-8C2024-04-04
10850023741919Cervos Platelet Separator Triple Pack ACDACER-PRP-TRIPLE-ACER-PRP-TRIPLE-A2024-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850016403179ActivSight Laparoscope 5.5mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403186ActivSight Laparoscope 10mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403261ActivSight Laparoscope 10mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00846159038644SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038651SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038668SCANLAN® InstrumentsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038675SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038682SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038699SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038705SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038712SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038729SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11