Tex-Care Medical
GUDID 00632195001793
10X48 IMP STKT
Flynt/Amtex, Inc.
Patient surgical drape, single-use| Primary Device ID | 00632195001793 |
| NIH Device Record Key | 66c974a7-11f4-475c-8367-89dff12a65bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tex-Care Medical |
| Version Model Number | 91161-048 |
| Company DUNS | 038730060 |
| Company Name | Flynt/Amtex, Inc. |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00632195001793 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K955749
FDA Product Code
| KKX | Drape, Surgical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
[00632195001793]
Radiation Sterilization;Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-08 |
| Device Publish Date | 2021-10-29 |
On-Brand Devices [Tex-Care Medical]
| 00632195002356 | 8X100YD COTTON PRE |
| 00632195002349 | 6X100YD COTTON PRE |
| 00632195002332 | 4X100YD COTTON PRE |
| 00632195002325 | 3X100YD COTTON PRE |
| 00632195002318 | 2"X50YD PRECONDITIONED COTTON |
| 00632195002301 | 12X100YD COTTON PRE |
| 00632195002295 | 10X100YD COTTON PRE |
| 00632195002288 | 4X100YD BLK COTTON |
| 00632195002271 | 3X100YD BLK COTTON |
| 00632195002264 | 2X50YD BLK COTTON |
| 00632195002257 | 10X100YD BLK COTTON |
| 00632195002240 | 8X100YD COTTON |
| 00632195002233 | 6X100YD COTTON |
| 00632195002226 | 4X100YD COTTON |
| 00632195002219 | 3X100YD COTTON |
| 00632195002202 | 2X50YD COTTON |
| 00632195002196 | 2X25 COTTON W/POLYBAG |
| 00632195002189 | 9X100YD POLY |
| 00632195002172 | 8X100YD POLY |
| 00632195002165 | 6X100YD POLY |
| 00632195002158 | 4X100YD POLY |
| 00632195002141 | 3X100YD POLY |
| 00632195002134 | 2X50YD POLY |
| 00632195002127 | 12X100YD POLY |
| 00632195002110 | 8X72 DP POLY |
| 00632195002103 | 6X60 DP POLY |
| 00632195002097 | 6X48 DP POLY |
| 00632195002080 | 4X48 DP POLY |
| 00632195002073 | 4X36 DP POLY |
| 00632195002066 | 6X60 SP POLY |
| 00632195002059 | 6X48 SP POLY |
| 00632195002042 | 4X48 SP POLY |
| 00632195002035 | 6X72 DP POLY |
| 00632195002028 | 8X48 IMP STKT |
| 00632195002011 | 6X48 IMP STKT |
| 30632195002005 | 4X25 POLY ANTIMICRO |
| 30632195001992 | 3X25 POLY ANTIMICRO |
| 30632195001985 | 2X25 POLY ANTIMICRO |
| 30632195001978 | 1X25 POLY ANTIMICRO |
| 30632195001961 | 2X25 BLACK COTTON TUBULAR |
| 30632195001954 | 6X50YD BIAS 45 DEGREE |
| 30632195001947 | 4X50YD BIAS 45 DEGREE |
| 30632195001930 | 3X50YD BIAS 45 DEGREE |
| 00632195001922 | 6"X50YD BIAS CC UNBOXED |
| 00632195001915 | 4"X50YD BIAS CC UNBOXED |
| 00632195001908 | 3"X50YD BIAS CC UNBOXED |
| 00632195001885 | 2"X50YD BIAS CC UNBOXED |
| 00632195001878 | 3X50YD 45 BIAS PRE UNBOXED |
| 00632195001861 | 2X50YD BIAS 45 BIAS PRE UNBOXED |
| 00632195001854 | 12X48 IMP STKT |
Trademark Results [Tex-Care Medical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TEX-CARE MEDICAL 75027676 2192510 Live/Registered |
Flynt/Amtex, Inc. 1995-12-04 |
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