Primary Device ID | 10850075308030 |
NIH Device Record Key | 98f9abe2-cdb9-49ba-9d22-276f8159c7da |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HYDRACELL-ORTHO-10 |
Version Model Number | 11 Gauge x 6.1CM 10cc |
Catalog Number | HYDRA-ORTHO-10 |
Company DUNS | 121622872 |
Company Name | RANFAC CORP. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | true |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 5085884400 |
info@ranfac.com | |
Phone | 5085884400 |
info@ranfac.com | |
Phone | 5085884400 |
info@ranfac.com |
Needle Gauge | 11 Gauge |
Length | 6.1 Centimeter |
Needle Gauge | 11 Gauge |
Length | 6.1 Centimeter |
Needle Gauge | 11 Gauge |
Length | 6.1 Centimeter |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850075308033 [Primary] |
GS1 | 10850075308030 [Package] Contains: 00850075308033 Package: CASE [1 Units] In Commercial Distribution |
KNW | Instrument, Biopsy |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-10-03 |
Device Publish Date | 2025-09-25 |
10850075308016 - HYDRACELL-ORTHO-5 | 2025-10-03 HYDRACELL-ORTHO-5 F/G, STERILE P/N 77134-01M |
10850075308030 - HYDRACELL-ORTHO-10 | 2025-10-03HYDRACELL-ORTHO-10, F/G, STERILE P/N 77135-01M |
10850075308030 - HYDRACELL-ORTHO-10 | 2025-10-03 HYDRACELL-ORTHO-10, F/G, STERILE P/N 77135-01M |
10850075308047 - HYDRACELL-EXT-5 | 2025-10-03 HYDRACELL-EXT-5 F/G, STERILE P/N 77136-01M |
10850075308061 - HYDRACELL-EXT-10 | 2025-10-03 HYDRACELL-EXT-10, F/G, STERILE P/N 77137-01M |
10850075308115 - Cervos Platelet Separator Triple Pack B2 | 2025-07-31 CER-PRP TRIPLE PACK B2 F/G, STERILE PN 76159-01M |
00850075308002 - Ranfac Biopsy Needle, 11GA, 4" | 2025-06-09 RBN-114SS, F/G, Sterile PN 74441-01M Customer # 0019886 |
10850075308023 - Cervos Platelet Separator Single 5 Pack | 2025-05-22 CER-PRP-SINGLE-5 F/G, STERILE PN 76158-01M |
10850023741995 - CER-SUB-1590 CE | 2024-10-25 CER-SUB-1590, CE, F/G, STERILE, P/N 74439-01M |