| Primary Device ID | 00850301007013 |
| NIH Device Record Key | a5636300-096e-408a-9ffa-38e31eaa07f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spectrum, Inc. |
| Version Model Number | 982-03560-000 |
| Catalog Number | 706920 |
| Company DUNS | 080458964 |
| Company Name | SPECTRUM, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(214)492-0506 |
| hfahrlander@spectrumlabs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850301007006 [Primary] |
| GS1 | 00850301007013 [Package] Contains: 00850301007006 Package: Inner Box [25 Units] In Commercial Distribution |
| GS1 | 00850301007327 [Package] Package: Shipper [50 Units] In Commercial Distribution |
| KKX | Drape, surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850301007013]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-30 |
| 10855495007402 | Non-Sterile Heel/Elbow Protection Cushion |
| 10855495007386 | Sterile Equipment Drape, Microlase, 5" X 59", latex Free |
| 10855495007372 | Non-sterile Equipment Drape, Disposable Sheath, Bulk |
| 10855495007365 | Sterile Equipment Drape, AssistArm Surgical Drape, 7" X 96", Latex Free |
| 10855495007358 | Sterile Equipment Drape, 12" X 100" w/Bag Clip, Latex Free |
| 10855495007348 | Sterile Equipment Drape, ESS Universal Camera Drape, 7" X 96", Latex Free |
| 20855495007331 | Sterile Equipment Drape, Josnoe Gama Probe Cover, 5" X 96", Latex Free |
| 20855495007324 | Sterile Equipment Drape, Tetra Mobile X-Ray Image Intensifier |
| 10855495007310 | 1 Ply Stockinette- 50/50% - 6" X 6 Yards - Sterile |
| 10855495007303 | 1 Ply Stockinette- 50/50% - 6" X 5 Yards - Sterile |
| 10855495007297 | 1 Ply Stockinette- 50/50% - 6" X 4 Yards - Sterile |
| 10855495007280 | 1 Ply Stockinette- 50/50% - 4" X 5 Yards - Sterile |
| 10855495007273 | 1 Ply Stockinette- 50/50% - 4" X 4 Yards - Sterile |
| 10855495007266 | 1 Ply Stockinette- 50/50% - 4" X 3 Yards - Sterile |
| 10855495007259 | 1 Ply Stockinette- 50/50% - 2" X 4 Yards - Sterile |
| 10855495007242 | Stockinette- 50/50% - Bias, 6" X 6 Yards - Sterile |
| 10855495007235 | Stockinette- 50/50% - Bias, 6" X 5 Yards - Sterile |
| 10855495007228 | Stockinette- 50/50% - Bias, 6" X 4 Yards - Sterile |
| 10855495007211 | Stockinette- 50/50% - Bias, 4" X 5 Yards - Sterile |
| 10855495007204 | Stockinette- 50/50% - Bias, 4" X 4 Yards - Sterile |
| 10855495007198 | Stockinette- 50/50% - Bias, 4" X 3 Yards - Sterile |
| 10855495007181 | Stockinette- 50/50% - Bias, 3" X 4 Yards - Sterile |
| 10855495007174 | Stockinette, Bulk, 50/50 Blend Tubular, 8" x 25 Yards, Non-sterile |
| 10855495007167 | Stockinette, Bulk, 50/50 Blend Tubular,6" x 25 Yards, Non-sterile |
| 10855495007150 | Stockinette, Bulk, 50/50 Blend Tubular, 4" x 25 Yards, Non-sterile |
| 10855495007143 | Stockinette, Bulk, 50/50 Blend Tubular, 3" x 25 Yards, Non-sterile |
| 10855495007136 | Stockinette, Bulk, 50/50 Blend Tubular, 2" x 25 Yards, Non-sterile |
| 10855495007129 | Hy'N Dry Stockinette, Impervious, 12" X 5' with straps, Sterile |
| 10855495007112 | Hy'N Dry Stockinette, Impervious, 10" X 4', with straps, Sterile |
| 10855495007105 | Hy'N Dry Stockinette, Impervious, 8"X 4' with straps, Sterile |
| 10855495007099 | Hy'N Dry Stockinette, Impervious, Hips/Legs Large, Sterile |
| 10855495007082 | Hy'N Dry Stockinette, Impervious, Hips/Legs Regular, Sterile |
| 10855495007075 | Hy'N Dry Stockinette, Impervious,Arms/Legs, Small, Sterile |
| 10855495007068 | 2 Ply Stockinette, 50/50, 8" X 5', Sterile |
| 10855495007051 | 2 Ply Stockinette, 50/50, 8" X 6', Sterile |
| 10855495007044 | 2 Ply Stockinette, 50/50, 6" X 6', Sterile |
| 10855495007037 | 2 Ply Stockinette, 50/50, 6" X 5', Sterile |
| 10855495007020 | 2 Ply Stockinette, 50/50 ,6" X 4.5', Sterile |
| 10855495007013 | 2 Ply Stockinette, 50/50, 6" X 4', Sterile |
| 10855495007006 | 2 Ply Stockinette, 50/50, 6" X 3', Sterile |
| 10850301007997 | 2 Ply Stockinette, 50/50, 4" X 6', Sterile |
| 10850301007980 | 2 Ply Stockinette, 50/50, 4" X5', Sterile |
| 10850301007966 | 2 Ply Stockinette, 50/50, 4" x 3', Sterile |
| 10850301007959 | 2 Ply Stockinette, 50/50, 3" X 4', Sterile |
| 10850301007942 | 2 Ply Stockinette, 50/50, 3" X 3', Sterile |
| 10850301007935 | 2 Ply Stockinette, 50/50, 2" X 4', Sterile |
| 10850301007928 | Strap-Stroll Stockinette, 8" X 6', Sterile |
| 10850301007911 | Strap-Stroll Stockinette, 8" X 5', Sterile |
| 10850301007904 | Strap-Stroll Stockinette, 6" X 6', Sterile |
| 10850301007898 | Strap-Stroll Stockinette, 6" X 5', Sterile |