FDA.reportPublic FDA data

ASK-1 Aspiration Starter Kit

Primary DI
00857878007255
Brand
ASK-1 Aspiration Starter Kit
Company
RANFAC CORP.
Model
1
Catalog number
ASK-1
Device description
ASK-1, Aspiration Starter KitP/N 74312-01M
Published
2018-03-07
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
POZBiopsy Needle Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POZBiopsy Needle KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857878007252PackageGS15In Commercial Distribution
20857878007259PackageGS13Not in Commercial Distribution
30857878007256PackageGS14In Commercial Distribution
00857878007255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085787800725210857878007252
2085787800725920857878007259
3085787800725630857878007256
00857878007255008578780072558578780072550857878007255

GMDN Terms#

Term, Definition table
TermDefinition
Surgical dressing/drape kit, single-useA collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
5085884400info@ranfac.com

Regulatory Flags#

DUNS number
121622872
Device count
1
Premarket exempt
true
Kit
true
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
16931918144559InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2024-02-02
16931918163949InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2024-02-02
26931918144556InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2024-02-02
26931918163946InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2024-02-02
16931918148892InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2023-10-20
26931918148899InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2023-10-20
10195594354534CARDINAL HEALTHCardinal Health 200, LLCPOZ2021-10-31
50195594354532CARDINAL HEALTHCardinal Health 200, LLCPOZ2021-10-31
20857878007259ASK-1 Aspiration Starter KitRANFAC CORP.POZ2018-03-07
00815277022057CuraplexBOUND TREE MEDICAL, LLCPOZ2016-12-14