| Primary Device ID | 00810007662046 |
| NIH Device Record Key | 2444ec69-f0af-4139-8097-3c5a1d4af771 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sable |
| Version Model Number | 600-SP |
| Company DUNS | 026777252 |
| Company Name | HOURGLASS INTERNATIONAL INC |
| Device Count | 6 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810007661940 [Unit of Use] |
| GS1 | 00810007661995 [Primary] |
| GS1 | 00810007662046 [Package] Contains: 00810007661995 Package: Case [100 Units] In Commercial Distribution |
| LZA | Polymer Patient Examination Glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-23 |
| Device Publish Date | 2023-05-15 |
| 00810007662084 | Nitrile Powder Free Examination Gloves, XL, Black, 6/PK, Sample, Tested for Use with Chemotherap |
| 00810007662077 | Nitrile Powder Free Examination Gloves, L, Black, 6/PK, Sample, Tested for Use with Chemotherapy |
| 00810007662060 | Nitrile Powder Free Examination Gloves, M, Black, 6/PK, Sample, Tested for Use with Chemotherapy |
| 00810007662053 | Nitrile Powder Free Examination Gloves, S, Black, 6/PK, Sample, Tested for Use with Chemotherapy |
| 00810007662046 | Nitrile Powder Free Examination Gloves, XS, Black, 6/PK, Sample, Tested for Use with Chemotherap |
| 00810007661414 | Nitrile Powder Free Examination Gloves, XL, Black, 250/BX, Tested for Use with Chemotherapy Drug |
| 00810007661407 | Nitrile Powder Free Examination Gloves, L, Black, 300/BX, Tested for Use with Chemotherapy Drugs |
| 00810007661391 | Nitrile Powder Free Examination Gloves, M, Black, 300/BX, Tested for Use with Chemotherapy Drugs |
| 00810007661384 | Nitrile Powder Free Examination Gloves, S, Black, 300/BX, Tested for Use with Chemotherapy Drugs |
| 00810007661377 | Nitrile Powder Free Examination Gloves, XS, Black, 300/BX, Tested for Use with Chemotherapy Drug |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SABLE 98625394 not registered Live/Pending |
Exemplis LLC 2024-06-28 |
![]() SABLE 90655812 not registered Live/Pending |
SUNVALLEY (HK) LIMITED 2021-04-19 |
![]() SABLE 90633472 not registered Live/Pending |
SUNVALLEYTEK INTERNATIONAL, INC. 2021-04-08 |
![]() SABLE 90633469 not registered Live/Pending |
SUNVALLEYTEK INTERNATIONAL, INC. 2021-04-08 |
![]() SABLE 88594414 not registered Live/Pending |
C-Stacks Inc. 2019-08-27 |
![]() SABLE 88406766 not registered Live/Pending |
Ehab Harb 2019-04-29 |
![]() SABLE 87978314 5576024 Live/Registered |
Sunvalley (HK) Limited 2017-02-28 |
![]() SABLE 87977207 not registered Dead/Abandoned |
Sunvalley (HK) Limited 2017-02-28 |
![]() SABLE 87803957 5676919 Live/Registered |
MS Blue Rice & Grain, LLC 2018-02-20 |
![]() SABLE 87658478 5593602 Live/Registered |
SUNVALLEY (HK) LIMITED 2017-10-24 |
![]() SABLE 87494978 not registered Live/Pending |
GLOBUS MEDICAL, INC. 2017-06-19 |
![]() SABLE 87352106 not registered Live/Pending |
Sunvalley (HK) Limited 2017-02-28 |