SLEEVE
- Primary DI
- 00840186696136
- Brand
- SLEEVE
- Company
- BURLINGTON MEDICAL, LLC
- Model
- R8SL
- Device description
- Sleeve .5mm Xenolite 800 NL Size Tailored
- Published
- 2022-09-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| IWO | Apron, Protective |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| IWO | Apron, Protective | Radiology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00840186696136 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00840186696136 | 00840186696136 | 840186696136 | 0840186696136 |
GMDN Terms
| Term | Definition |
|---|
| Surgical sleeve cover | A forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device. |
Regulatory Flags
- DUNS number
- 083381202
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| G242JL5N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-14 |
| G242JM3N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-14 |
| G242JX3N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-14 |
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| G242JP5N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242JS3N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242JS5N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242K23N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242K25N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
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| G242KL5N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242KM3N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242KM5N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242KP3N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242KP5N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242KS3N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242KS5N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242KX3N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
| G242KX5N90 | Techno-Aide | Techno-Aide, Inc. | IWO | 2024-11-13 |
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