| Primary Device ID | 00815384022339 | 
| NIH Device Record Key | 40218dc5-be6d-4cbc-abcf-9ad4c7c3d49e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | OPTICS ONE | 
| Version Model Number | 9951-20NS | 
| Catalog Number | 9951-20NS | 
| Company DUNS | 790514756 | 
| Company Name | MEDICAL TECHNIQUE, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 520-733-7999 | 
| INFO@MTIDRAPE.COM | |
| Phone | 520-733-7999 | 
| INFO@MTIDRAPE.COM | |
| Phone | 520-733-7999 | 
| INFO@MTIDRAPE.COM | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00815384022322 [Primary] | 
| GS1 | 00815384022339 [Package] Contains: 00815384022322 Package: CASE [20 Units] In Commercial Distribution | 
| KKX | Drape, Surgical | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00815384022339]
Ethylene Oxide
[00815384022339]
Ethylene Oxide
[00815384022339]
Ethylene Oxide
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2016-09-24 | 
| 00815384023596 | Mini C-arm Drape Kit 46 x 72 | 
| 00815384023589 | General Purpose Probe Cover 6" x 96" | 
| 00815384023565 | General Purpose Probe Cover 6" x 48" | 
| 00815384023541 | General Purpose Probe Cover 5" x 96" | 
| 00815384023527 | General Purpose Probe Cover 5" x 48" | 
| 00815384023398 | Leica/Wild Microscope Drape M680 54 x 150 - Foam Ring | 
| 00815384023367 | Esmark Bandage 6n x 12ft | 
| 00815384023343 | Esmark Bandage 6in x 9ft | 
| 00815384023329 | Esmark Bandage 4in x 12ft | 
| 00815384023305 | Esmark Bandage 4in x 9ft | 
| 00815384023282 | Patient/OR Table Strap - 4 in wide | 
| 00815384023275 | Esmark Bandage 3in x 12ft | 
| 00815384023251 | Esmark Bandage 3in x 9ft | 
| 00815384023237 | Patient/OR Table Strap - 3 in wide | 
| 00815384023220 | Armboard Straps 1 x 30 | 
| 00815384023206 | Sterile Clear View Leg Drape | 
| 00815384023176 | Blair Wand Drape | 
| 00815384023152 | Gamma Probe Drape | 
| 00815384023138 | Leica/Wild Microscope Drape M840 54 x 90 - Foam Ring | 
| 00815384023107 | Leica/Wild Microscope Drape M840 54 x 62 - Foam Ring Non Sterile | 
| 00815384023084 | Leica/Wild Microscope Drape M840 54 x 62 - Foam Ring | 
| 00815384023053 | Ultrasound Probe Drape w/gel 5 X 96 | 
| 00815384023039 | Ultrasound Probe Drape w/gel 4 X 96 | 
| 00815384023015 | Ultrasound Probe Drape w/gel 6 X 96 | 
| 00815384022995 | Ultrasound Probe Drape w/gel 6 x 48 | 
| 00815384022971 | Probe Cover 5 x 48 with Gel | 
| 00815384022957 | Domed Bag 26in Deep | 
| 00815384022926 | Domed Bag 22in Deep | 
| 00815384022896 | Domed Bag 18in Deep | 
| 00815384022865 | Domed Bag 14in Deep | 
| 00815384022834 | Bandbag Latex Free Band & Tape 40 x 40 | 
| 00815384022803 | Bandbag Latex Free Band & Tape 36 x 36 | 
| 00815384022773 | Bandbag Latex Free Band & Tape 36 x 30 | 
| 00815384022742 | Bandbag Latex Free Band 36 x 20 | 
| 00815384022711 | Bandbag Latex Free Band 30 x 30 | 
| 00815384022681 | Bandbag Latex Free Band 30 x 20 | 
| 00815384022650 | Poly Post Drape 20 x 80 | 
| 00815384022629 | Poly Slush Machine Drape 54 x 54 | 
| 00815384022605 | OB/GYN Underbuttocks Cover 39 x 44 w/absorbent pad | 
| 00815384022575 | C-arm Extra Long w/4 Poly Straps 42 x 120 | 
| 00815384022544 | C-arm Extra Long w/Poly Straps 54 x 90 Banded Bag | 
| 00815384022513 | Tank Cover 20 x 62 Non Sterile | 
| 00815384022490 | Combo C-arm Cover with Band Bag 44 x 77(c-arm)-36x30(Bandbag) | 
| 00815384022469 | X-ray Cassette Cover 24 x 24 w/ Release Liner - Non Sterile | 
| 00815384022445 | X-ray Cassette Cover 24 x 24 w/ Release Liner | 
| 00815384022414 | Cassette Cover 20X40 Tuck & Fold Non Sterile | 
| 00815384022391 | X-ray Cassette Cover 20 x 40 Fold and Tuck Closure | 
| 00815384022360 | X-ray Cassette Cover 24 x 24 Adhesive Closure | 
| 00815384022339 | C-arm Drape 44 x 77 Gusset Fit - Non Sterile | 
| 00815384022315 | C-arm Drape 44 x 77 Gusset Fit | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  OPTICS ONE  75848395  2404052 Dead/Cancelled | Medical Technique, Inc. 1999-11-15 |