Sydney IVF K-SIGB-50-AA
GUDID 00827002463189
SYDNEY IVF, GAMETE BUFFER
WILLIAM A. COOK AUSTRALIA PTY. LTD.
IVF medium kit| Primary Device ID | 00827002463189 |
| NIH Device Record Key | 2a4f551d-b8f8-4c6b-9d55-e48ae5f4c833 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sydney IVF |
| Version Model Number | G46318 |
| Catalog Number | K-SIGB-50-AA |
| Company DUNS | 758568000 |
| Company Name | WILLIAM A. COOK AUSTRALIA PTY. LTD. |
| 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 | false |
| 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 |
Customer Support Contacts
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com | |
| Phone | +1(812)330-5494 |
| sharedservices@cookmedical.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002463189 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153478
FDA Product Code
| MQL | MEDIA, REPRODUCTIVE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-15 |
On-Brand Devices [Sydney IVF]
| 00827002463202 | SYDNEY IVF, GAMETE BUFFER |
| 00827002463189 | SYDNEY IVF, GAMETE BUFFER |
| 00827002463172 | SYDNEY IVF, GAMETE BUFFER |
| 00827002463165 | SYDNEY IVF, SPERM MEDIUM |
| 00827002463158 | SYDNEY IVF, SPERM MEDIUM |
| 00827002463141 | SYDNEY IVF, SPERM MEDIUM |
| 00827002463134 | SYDNEY IVF, SPERM GRADIENT KIT |
| 00827002463127 | SYDNEY IVF, SPERM GRADIENT KIT |
| 00827002463110 | SYDNEY IVF, SPERMIENT |
| 00827002463103 | SYDNEY IVF, SPERMIENT |
| 00827002463097 | SYDNEY IVF, SPERM CRYOPRESERVATION BUFFER |
| 00827002463080 | SYDNEY IVF, FOLLICLE FLUSH BUFFER |
| 00827002463073 | SYDNEY IVF, FERTILIZATION MEDIUM |
| 00827002463066 | SYDNEY IVF, FERTILIZATION MEDIUM |
| 00827002463059 | SYDNEY IVF, FERTILIZATION MEDIUM |
| 00827002463042 | SYDNEY IVF, HYALURONIDASE |
| 00827002463035 | SYDNEY IVF, PVP |
| 00827002463028 | SYDNEY IVF, CLEAVAGE MEDIUM |
| 00827002463011 | SYDNEY IVF, CLEAVAGE MEDIUM |
| 00827002463004 | SYDNEY IVF, CLEAVAGE MEDIUM |
| 00827002462991 | SYDNEY IVF, EMBRYO BIOPSY MEDIUM |
| 00827002462984 | SYDNEY IVF, CRYOPRESERVATION KIT |
| 00827002462977 | SYDNEY IVF, THAWING KIT |
| 00827002462960 | SYDNEY IVF, BLASTOCYST MEDIUM |
| 00827002462953 | SYDNEY IVF, BLASTOCYST MEDIUM |
| 00827002462946 | SYDNEY IVF, BLASTOCYST CRYOPRESERVATION KIT |
| 00827002462939 | SYDNEY IVF, BLASTOCYST THAWING KIT |
| 00827002462922 | SYDNEY IVF, BLASTOCYST VITRIFICATION KIT |
| 00827002462915 | SYDNEY IVF, BLASTOCYST WARMING KIT |
Trademark Results [Sydney IVF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYDNEY IVF 79029725 3631466 Dead/Cancelled |
Genea IP Holdings Pty Ltd 2006-07-24 |
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