FDA.reportPublic FDA data

STIFFENING CANNULA, 6CM F/G

Primary DI
00858690006594
Brand
STIFFENING CANNULA, 6CM F/G
Company
RANFAC CORP.
Model
6CM
Catalog number
SC-6CM
Device description
STIFFENING CANNULA, 6CM F/GSC-6CMPN 60001-04M
Published
2017-05-04
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K845038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K845038000BREAST & FOREIGN BODY LOCALIZATION INSTRUMENTRanfac, Corp.1985-03-11GDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858690006591PackageGS110In Commercial Distribution
20858690006598PackageGS150In Commercial Distribution
00858690006594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085869000659110858690006591
2085869000659820858690006598
00858690006594008586900065948586900065940858690006594

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
Length6Centimeter
Needle Gauge23Gauge

Contacts#

Phone, Email table
PhoneEmail
5085884400info@ranfac.com

Regulatory Flags#

DUNS number
121622872
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023741226Cervos Flex Bone Marrow Aspiration Needle8 Gauge x 9.1cmCER-FLEX2021-07-16
00850023741462CER-LA11 GA X 16.5 CMCER-LA2021-11-10
00850023741479CER-FLEX8 GA X 9.1 CMCER-FLEX2021-11-10
00858690006808Cervos Lipo Pro Double PackCER-LP-40CER-LP-402022-09-19
00850023741561CERVOS PLATELET SEPARATOR 80 KITCER-PRP-80CER-PRP-802026-03-30
00850075308088CER-PRP-160 STERILITY PACKCER-PRP-160-SCER-PRP-160-S2026-03-30
00850075308101CER-PRP-160 KitCER-PRP-160CER-PRP-1602026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILECER-PRP-40CER-PRP-402026-03-30
M9797405001M0NDL, RBN-114, STERILE, F/G"11 GAUGE x 4"""RBN-1142017-05-08
M9797405003M0NDL, RBN-133, STERILE, F/G"13 GAUGE x 3"""RBN-1332017-05-08
M9797405005M0NDL, RBN-132"13 GAUGE x 2"""RBN-1322017-05-08
M9797405006M0NDL, RBN-84, STERILE, F/G"8 GAUGE x 4"""RBN-842017-05-08
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
00850075308095CER-PRP-SINGLE-ACER-PRP-SINGLE-ACER-PRP-SINGLE-A2025-10-08
00850075308019HYDRACELL-ORTHO-511 Gauge x 6.1CM 5ccHYDRA-ORTHO-52025-09-25
00850075308033HYDRACELL-ORTHO-1011 Gauge x 6.1CM 10ccHYDRA-ORTHO-102025-09-25
00850075308040HYDRACELL-EXT-511 Gauge x 6.3 CM 5ccHYDRA-EXT-52025-09-25
00850075308064HYDRACELL-EXT-1011 Gauge x 6.3 CM 10ccHYDRA-EXT-102025-09-25

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
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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